16 SEPTEMBER 2011, VOLUME 12, ISSUE 37

HIV-positive Rwandans in discordant relationships will start taking antiretroviral treatment (ART) as soon as they test positive as part of a plan to boost national HIV prevention and treatment efforts. "There is evidence that antiretroviral treatment, once started early for eligible HIV-positive patients, alleviates their suffering and reduces the devastating impact of the pandemic," Anita Asiimwe, head of the Institute of HIV/AIDS Disease Prevention and Control, told IRIN/PlusNews...  According to the government, an estimated 7.1 percent of cohabiting couples seeking voluntary counselling and testing services in the capital, Kigali, are HIV discordant. Infections within stable relationships have been identified as one of the main sources of new cases in Rwanda. Rwanda has a successful ART programme; Asiimwe said the country had achieved 93 percent coverage of people needing treatment under UN World Health Organization (WHO) guidelines, which recommend initiation of treatment at a CD4 count - a measure of immune strength - of 350 and below.

"HIV-positive people in discordant relationships will start ART regardless of their CD4 count," said Sabin Nsanzimana, coordinator of the HIV and Sexually Transmitted Infections (STI) Care and Treatment Department at the Ministry of Health's Centre for Treatment and Research on AIDS, Malaria, Tuberculosis and other Epidemics, TRAC Plus... Rwanda is going ahead despite the fact that WHO has not yet released prevention guidelines for discordant couples... Nsanzimana said the added cost of putting thousands more people on treatment would be compensated for by the reduction in new HIV infections and treatment down the line... The Rwandan government will have to intensify awareness-raising campaigns: HIV testing remains low, especially among couples... The head of HIV and STI care and treatment at the Rwanda Biomedical Centre, Muhayimpundu Ribakare, said: "Here in Rwanda it's just very few couples that go for HIV voluntary counselling and testing services; of course this means they are not aware of their HIV status - if they are positive they end up infecting their partners." According to Nsanzimana, the government will also need to intensify its efforts to improve ART adherence to ensure patients do not develop resistance...

Gay men will be able to give blood when government restrictions are lifted later this year, the Department of Health has said. A lifetime ban on blood donation by men who have had sex with another man was put in place in the UK in the 1980s as a response to the spread of AIDS and HIV. But following a review by the Advisory Committee on the Safety of Blood, Tissues and Organs (Sabto), men who have not had homosexual sex within the past year will be able to donate if they meet certain other criteria.

AIDS intervention programs have reduced HIV transmission from pregnant women to their unborn fetuses, said a senior health official on Friday. In the areas covered by the programs, 7.9 percent of HIV-positive mothers transmitted the virus to their babies, down 33 percent prior to the programs being initiated in 2003, said Fu Wei, a senior official with the Ministry of Health, at a press conference. China started a pilot program of providing free HIV tests and follow-up health counselling for pregnant women in 2003 in eight counties of five provinces and expanded it to 1,156 counties in 31 provincial divisions in 2010, Fu said. The ministry launched the programs in wake of a rapid increase of HIV-positive females, he said. As of June, a total of 17,202 pregnant women were diagnosed as HIV positive, he said. In 2010, the country added free syphilis and hepatitis B testing in the intervention programs. In 2010, about 839 million yuan (129 million U.S. dollars) from the central budget was spent in the programs that covered 6.4 million pregnant women, accounting for about 44 percent of the total expectant mothers in China.

Michel Kazatchkine and Eric Goosby may be able to halt the spread of HIV. They just need the money. The two men control the funds that buy drugs for most of the world's AIDS patients. Studies in July provided the strongest evidence yet that medicines used since 1994 to treat HIV can almost eliminate the chance an infected person will pass the virus to a sex partner. Given to healthy people, the treatments can also protect against infection, offering the potential to end a pandemic that has killed 30 million people in 30 years. Governments are now planning projects to assess whether those findings can be replicated in the real world, and what that might cost. Getting the drugs just to those patients who should be treated under existing guidelines would cost another $6 billion a year, according to the United Nations. Treating all those infected, in some of the world's poorest countries, would cost tens of billions more. Finding more money will be difficult with economic growth stalling and nations including the U.S., the biggest donor to the AIDS fight worldwide, trying to curtail overall spending to rein in debt. Funding for AIDS in poorer nations fell 10 percent to $6.9 billion in 2010 from 2009 levels, according to the UN. "We may well be able to overcome AIDS," Kazatchkine, the director of the Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria, said in an interview. Still, "the gap between what the science is telling us we can achieve and what we would be able to achieve is at risk of increasing..."

Under current World Health Organization guidelines, however, patients don't start treatment until their immune systems deteriorate to a certain level, postponing side effects that may include kidney damage and nausea and reducing costs... At a special session of the United Nations General Assembly in New York in June, world leaders agreed to expand treatment to all 15 million patients by 2015, and committed to increase funding to at least $22 billion a year from $16 billion now. The WHO plans to make guidelines available within 12 months on how to use antiretrovirals for prevention, said Gottfried Hirnschall, the director of the Geneva-based agency's HIV/AIDS department... While the latest data may give policymakers a new weapon in the fight against AIDS, they also present them with choices about how to allocate resources, and which approach is the best investment, said Helen Rees, co-chair of the South African National AIDS Council's Programme Implementation Committee. "In the absence of a guideline that will come in a year, we've got to make a decision," Rees said in Rome. "Do we keep pouring condoms into the system, or is there a glass ceiling? Are we going to now buy 600 million condoms or a billion? It's that level of decision-making." ... While the latest trials support starting treatment even earlier than current guidelines recommend, Kazatchkine said the first priority must be to treat the 9 million people who need the pills now just to survive and aren't getting them. I cannot prioritize treatment for a patient with 800 CD4 cells when there's still a line of patients with less than 200," he said...

"People are coming in for treatment far too late," said Tim Hallett, a researcher at Imperial College London who has developed mathematical models of what effect the new findings might have and what conditions would be needed to achieve the best results. "They've already done most of the transmission they're going to do by the time you see them in the clinic..." When Kazatchkine passed the hat around at the Global Fund's triennial replenishment meeting in New York last year, he got $11.7 billion, less than the $13 billion he needed to keep putting patients on treatment at current rates, and a little more than half of the $20 billion he wanted to make serious inroads into the pandemic... The U.S. is now talking to European governments, along with those such as China, Saudi Arabia and South Korea that haven't been major contributors previously, to increase their spending, Goosby said. "We are now in a position where the global community needs to share in this responsibility more aggressively and bring resources toward it," he said in an interview. "We are so close to this goal, that now the conversation must shift to, 'You need to do your part so we can get across the finish line.'"

The Bill & Melinda Gates Foundation today announced that Dr. Trevor Mundel has been named president of the foundation's Global Health Program. Mundel, who is currently global head of development for Novartis Pharma AG and is based in Basel, Switzerland, will start work at the foundation on December 1. In his new position, Mundel will lead the foundation's efforts to develop and deliver drugs, vaccines, and other tools to fight developing-world diseases, such as HIV/AIDS, tuberculosis, and malaria, and take the world closer to the goal of polio eradication. He will oversee the foundation's global health grant portfolio, which includes more than $14.7 billion in grants to date. Mundel has been a senior executive and scientist with Novartis since 2003, serving most recently as global head of development. He previously served as global head of immunology and infectious disease, global head of exploratory development, and head of exploratory clinical development. At Novartis, he oversaw some 140 clinical projects, a budget of $3 billion, and more than 7,500 employees... Prior to his tenure at Novartis, Mundel held senior positions at Alkermes, Inc., Pfizer and Parke-Davis. Mundel earned his bachelor's and medical degrees from the University of the Witwatersrand in Johannesburg, South Africa. He also studied mathematics, logic and philosophy at Balliol College, University of Oxford as a Rhodes Scholar, and earned his Ph.D. in mathematics at the University of Chicago. He also completed his residency requirements in neurology at the University of Chicago Hospitals.

The Senate passed an overhaul of the U.S. patent system that President Barack Obama has called crucial to his administration's effort to boost job growth. In an 89-9 vote yesterday, the Senate cleared a bill passed by the House in June that would fundamentally alter the way patents are reviewed and mark the biggest change to U.S. patent law since at least 1952. The measure, called the America Invents Act, now heads to the White House for Obama's signature. The legislation, H.R. 1249, would let the U.S. Patent and Trademark Office set its own fees and exercise greater control over its budget, providing the agency with more funding to address a backlog of almost 700,000 applications awaiting first review. Reducing the time it takes to give inventions legal protection will speed new products to the market and spur economic growth, according to the bill's supporters... The legislation, which culminates more than six years of negotiations and lobbying, covers every step of the patent process, setting new procedures to review issued patents while curtailing some litigation. It has the support of large companies including Microsoft Corp. (MSFT), International Business Machines Corp. (IBM) and a group that represents Johnson & Johnson (JNJ), Eli Lilly & Co. (LLY), 3M Co. (MMM) and General Electric Co. (GE)...

The funding provision, which also would let the agency increase fees paid by inventors and patent owners, is the cornerstone of the bill and has been a unifying issue even for those who oppose other provisions... The patent office is funded entirely by user fees. The Obama administration says the money is needed to hire more examiners and improve agency computer systems to cut the current 34-month wait for patent approval... The U.S. Chamber of Commerce, Washington's largest business lobbying organization, supported passage, as did the United Steelworkers. A group representing large technology companies including Google Inc. (GOOG), Apple Inc. (AAPL), and Intel Corp. (INTC) also backed the measure...

Gilead Sciences Inc's experimental four-drug HIV pill may need to do more than simply match the safety and effectiveness of existing therapies to meet its lofty sales expectations. Results for the second pivotal clinical trial for the combination drug are expected this month. The pill is likely to meet the study's goal of working as well as a combination of other medicines, analysts said, but it may need to show superiority to convince investors of its commercial potential and send Gilead shares higher. The biotechnology company said in August that its first pivotal trial of the pill, known as the Quad, met the goal of showing that it worked as well as Atripla, Gilead's current three-drug combination HIV pill... The Quad is seen as Gilead's most important pipeline product -- all of the components are owned by the company, and the Quad would extend the life of the company's lucrative HIV franchise. As of early 2011, about 80 percent of U.S. HIV patients and 72 percent of European HIV patients were treated with a Gilead drug... The Quad combines experimental integrase inhibitor elvitegravir and boosting agent cobicistat with Truvada, a pill consisting of Gilead's older HIV drugs Emtriva and Viread.

Most of the company's current drug sales -- which totaled $7.4 billion last year -- come from Atripla, a once-daily pill that combines Truvada with Bristol-Myers Squibb's Sustiva. Gilead earns no profit from the Bristol drug, and all of the Atripla components lose patent protection in the next few years. The second pivotal trial of the Quad is designed to show that it works as well as a combination of ritonavir-boosted Reyataz, a protease inhibitor sold by Bristol-Myers, and Truvada. RBC Capital Markets analyst Michael Yee puts the odds that the Quad will show superiority to the Reyataz regimen at 25 percent. A lower-cost generic version of Atripla could be on the market in 2018, and Gilead will need a compelling case to convince doctors that the Quad will benefit patients more than existing HIV drugs. If approved, the Quad would be the first single-tablet regimen for HIV to include an integrase inhibitor -- a new class of drugs designed to block the ability of the human immunodeficiency virus to replicate... Full safety data from the first trial will be presented at a medical conference in March, and Gilead plans to file for U.S. regulatory approval of the Quad in the first quarter of 2012... Sales of the Quad are forecast as high as $1.53 billion by 2015, but estimates vary widely. "While Gilead remains the dominant market leader in HIV ... we believe the overall market trends are slowing and that trends toward earlier treatment have been close to fully realized," BMO Capital Markets analyst Jim Birchenough said in a research note this week...

AIDS vaccine researchers say they have some new clues to help focus their search for a safe and effective vaccine against HIV. At the AIDS Vaccine conference in Bangkok on Tuesday, scientists announced an update to a Thai trial of a "modestly effective" experimental AIDS vaccine... The new findings shed light on how the vaccine worked by identifying how the immune system responded to it. Scientists have also discovered a part of HIV that may be vulnerable to a vaccine, which means scientists now have some idea of how the vaccine worked, and how to do more focused research. "It might be possible in the future to do vaccine trials with many fewer people much more rapidly so we could see progress occurring a lot more rapidly," said U.S. army Col. Jerome Kim, one of the leaders of the Thai trial. Stephen Kent, a vaccine researcher at the University of Melbourne, described the antibodies produced by the vaccine as "friends with benefits." "They don't necessarily prevent infection of cells but it allows them to kill infected cells," said Kent. "So it may be that that really helps protection."

The findings, along with the development of a test for the antibody response, may focus and speed up the vaccine research. Scientists want to take the findings back to the lab or clinic to try to improve the effectiveness of the Thai vaccine... But the vaccine and the immune response it created were specific to the type of HIV in Thailand, and the vaccine formulation used there, scientists cautioned. The findings suggested the vaccine had no effect on the amount of virus in the blood of those who became infected with HIV. Vaccination did seem to be associated with lower amounts of virus in genital fluids. New trials will begin this fall in Thailand to test a booster, and a similar vaccine trial is being planned in South Africa to try to replicate the Thai results. Despite the excitement, scientists agreed that before an HIV vaccine can be licensed for use, it will have to be more broadly effective, which is years away.

After 2 years of analyzing the results of the largest AIDS vaccine clinical trial ever held -- called RV144 - researchers say they have found 2 ways the immune system can respond, which could predict whether those inoculated will be protected or are more likely to become infected with HIV. The new data was released at the annual AIDS Vaccine conference, the largest scientific venue that brings together the world's top scientists, policy makers, community advocates and funders who focus exclusively on AIDS vaccine research... RV-144 was a phase III clinical trial of more than 16,000 healthy Thai adults. Trial results that were released in September 2009 found the vaccine was 31% effective in preventing HIV infections. Study investigators called it "modestly protective." They also suggested the study provided proof that a vaccine might be possible. Since then researchers have culled data from the study looking for clues as to why the vaccine protected some but not others. In this new study, they found that the vaccine produced 2 types of immune responses: One led to an increased vaccine efficacy, which means the vaccine would prevent infection. The other immune response led to the same infection rate as a placebo, according to Dr. Barton Haynes, Director of the Duke Human Vaccine Institute at Duke University School of Medicine... This latest advance comes on the heels of a number of scientific breakthroughs in HIV/AIDS research... But some researchers here say the vaccine is still the "holy grail." Which is why this news is getting such buzz at the conference. "It's exciting because it's the first time getting a glimpse of how an HIV vaccine works." Catherine Hankins, Chief Scientific Advisor, UNIAIDS said. "We need a vaccine if we are going to end the epidemic." Haynes says the next step is to continue mining the data for clues that will help them determine how researchers can anticipate what will happen in future trials. "Vaccines like HIV are difficult [to develop] because of the nature of the bug. It's requiring a more intense effort. There has never been a vaccine against a retrovirus in humans, so this is a new paradigm." But even with this modest advance researchers say, there's still a lot to be done before a vaccine is ready globally and for the general public.

Scientists say developing an HIV vaccine has been as challenging as developing one for malaria. Rick King from International AIDS Vaccine Initiative (IAVI) says due to the complexity and diversity of the HI Virus it's been impossible to design a broad vaccine that will match up to HIV. It's taken over 20 years for researchers and scientist to try to develop an HIV vaccine... People living with HIV in Thailand are subjected to compulsory HIV tests by potential employers and if found to be positive they do not get the job. This was revealed by Jintanat Anan-wora-nich, the Deputy Director in Scientific Affairs at the Thai Red Cross AIDS Research Centre. She was addressing journalists ahead of the AIDS Vaccine Conference which will begin in the Thai capital, Bangkok, today. Anan-wora-nich says the practice has been going on for years but there is very little government can do to stop it. "It's not a choice, they test everyone for HIV before accepting them into the workplace and after that some companies check every year. The companies refuse to employ people who are HIV positive even though this is illegal... It has been difficult to challenge this practise because people who are affected by the virus don't want to come out and complain because they don't want to show that they have HIV."

Two years ago, the AIDS community was electrified by news that a vaccine had partially protected people against HIV. Now this vaccine will be tested in South Africa. This is according to scientists attending the International AIDS Vaccine conference, which opened yesterday (Monday) in Bangkok. South Africa will be the first country outside of Thailand to have access to the only vaccine in 30 years to show any success against the virus that has killed millions of people, particularly in southern Africa. The vaccine, known as RV144, protected 31 percent of the people who received it in a massive clinical trial in Thailand involving 16 400 people. "The next step after the Thai trial was to rapidly test the vaccine in a country with a high incidence of HIV to see whether it would have the same results," said Wits University's Professor Glenda Gray. "But there are a lot of challenges that have delayed the process since the results were announced two years ago," added Gray, who will lead the RV144 vaccine research when it starts in South Africa. A key challenge has been to modify the Thai vaccine to fight the strain of HIV that is most common in South Africa...

"But the company making the Thai vaccine closed down after the trial, so there was no one to make the product," said [Wits University's Professor Glenda] Gray. "[Pharmaceutical companies] Novartis and Sanofi Pasteur are now working on making the vaccine, but first have to identify and insert parts of sub-type C into the primer vaccine." Gray predicts that the trial will be ready to start in 2014, and involve around 8 000 people in up to 12 sites in South Africa. The trial will be run by a collaboration of international and local groups, including the international HIV Vaccine Trials Network, the Gates Foundation and SA AIDS Vaccine Initiative (SAAVI), which is working with communities at various potential trial sites... SAAVI director Elise Levendal said she was very excited about the planned trial, adding that it was a credit to our country's scientists, government and community support for clinical trials that South Africa had been chosen. "We work with communities to educate them and prepare them for vaccine research, and they keep asking us 'when is there going to be a vaccine trial'," said Levendal. "Now we can finally tell them something is going to happen."...

An unlikely issue -- whether to vaccinate preadolescent girls against a sexually transmitted virus -- has become the latest flashpoint among Republican presidential candidates as they vie for the support of social conservatives and Tea Party members. The issue exploded Monday night when Representative Michele Bachmann and former Senator Rick Santorum attacked Gov. Rick Perry of Texas during a debate for issuing an executive order requiring sixth-grade girls to be vaccinated against the human papillomavirus, criticizing the order as an overreach of state power in a decision properly left to parents. Later, Sarah Palin, who has yet to announce her 2012 intentions, also found fault with Mr. Perry. The issue pushes many buttons with conservatives: overreach of government in health care decisions, suspicion that sex education leads to promiscuity and even the belief -- debunked by science -- that childhood vaccinations may be linked to mental disorders... The focus on Mr. Perry's record on the issue put him on the defensive during a debate for the second week in a row, this time among his core constituency of Tea Party voters...

Although Mrs. Bachmann called the HPV vaccine dangerous, a report last month from the Institute of Medicine, which advises the government, found that it was generally safe. There is no evidence linking it to mental retardation. The vaccine is strongly recommended by medical groups, including the American Academy of Pediatrics and the American Cancer Society, to prevent cervical cancer, which kills about 4,000 women in the United States annually. The recommended age of vaccination for girls is 11 or 12, before they become sexually active. But only Virginia and the District of Columbia require vaccination for middle school entry, according to the cancer society. Dr. Deborah Saslow, the cancer society's director of breast and gynecological cancer, said it did not advocate requiring HPV vaccinations before entering middle school, since parents and even doctors need more time to get used to the idea of the vaccine and to accept that it is safe. When Mr. Perry issued his executive order in 2007, he made Texas the first state to require vaccinations, although parents could opt out. The order was instantly controversial -- the State Legislature overturned it by bipartisan majorities before it could be carried out -- and criticisms were raised at the time that Mr. Perry was doing a favor for a former chief of staff, Mike Toomey, who was then a lobbyist for Merck, the maker of the first HPV vaccine on the market, Gardasil... Mrs. Bachmann's suggestion that HPV vaccines could be dangerous caused some influential conservative bloggers and broadcasters to suggest that she had carried the attack too far, raising questions about her judgment in echoing the thoroughly debunked views that vaccines are linked to autism or other mental illness. Rush Limbaugh on Tuesday said she "may have jumped the shark" with her linking of HPV vaccines to mental retardation. Appearing on the talk show of another conservative host, Sean Hannity, Mrs. Bachmann backpedaled a bit. "I am not a doctor, I am not a scientist, I'm not a physician," she said.

Most Somali women fleeing to northeastern Kenya's Dadaab in northeastern Kenya have never visited an antenatal clinic, let alone given birth in a hospital...Fatuma Ali, a 27-year-old Somali refugee, delivered all her five children at home. When she fled Somalia for Kenya 10 months ago, she was pregnant; community health workers in Dadaab persuaded her to attend a local antenatal clinic. "In my country there are no hospitals, and we don't even believe in going to the hospital... There are people who tell us it against our culture to go to hospital to give birth," she told IRIN. "After I was registered as a refugee here, I used to attend the clinic and they have even tested me for HIV; they have taught me how to feed my child and I received soap and sanitary towels soon after I delivered and went back home." Ali was also treated for complications that the doctors attributed to the fact that she had undergone female genital mutilation/cutting when she was a girl, and gave her family planning advice. "I am a refugee and I wonder how I can take care of many children... I have made a decision to stop giving birth," she said.

According to Beldina Gikundi, the reproductive health focal point for the International Rescue Committee (IRC) in Dadaab, community health workers have been crucial in boosting the uptake of reproductive health services among women in the camp. "Many women still believe in home delivery and many more people still do not believe in discussing issues of sexuality that easily, but with the use of community health workers, we have been able to reach out to them to seek both reproductive health and HIV services," she said. She noted that a number of women also sought rape and post-abortion counselling and treatment, as well as screening for sexually transmitted infections. However, limited health facilities at the camp are struggling to cope with the high demand for services. Thousands of Somalis continue to arrive in Dadaab daily, mostly women and children, but only the IRC and Medecins Sans Frontieres have fully operational maternal health facilities in the camp...

African leaders are being challenged to commit themselves to the fight against HIV-AIDS by allocating more resources for research into finding a cure. An official of HIV Vaccine Trials Network, an international collaboration of scientists searching for effective and safe vaccines, says Africa should go beyond donor recipients to contributing positively to HIV vaccine research. Executive Director, Dr. James Kublin, says though the continent faces economic challenges, there is a lot Africa can offer if leadership demonstrates commitment. He spoke to Nhyira FM's Ohemeng Tawiah at a training programme for journalists ahead of this year's AIDS Vaccine Conference in Bangkok, Thailand... [Kublin] lauded efforts by scientists to find effective and safe HIV vaccines because he believes such intervention provides hope for people living with the disease. Dr. Kublin however criticized African politicians for providing inaccurate data on HIV prevalence in their respective countries for political expediency... He said though some African governments have done well, especially, in reducing discrimination and stigmatization, the same cannot be said of resource allocation for research. Dr. Kublin believes any such contribution from African leaders would be "a great gesture no matter how small it would be. "African countries now have many economic challenges. We know that, but I think it would be very encouraging to see African leadership contributing to HIV Vaccine research and development", Dr. Kublin explained. "It may not be a major portion of the work that is being done. But if they can contribute just a small amount, it would be a great gesture to the world that they are also committed to ending this global problem". "I would love to see more advocacies by the African politicians and leadership for HIV vaccine research"...

Inovio Pharmaceuticals (NYSE:INO) said on Tuesday that its global HIV vaccine has demonstrated strong immune responses and safety in an early-stage study. The Blue Bell, Pa.-based maker of vaccines against cancer and infectious diseases presented the early results of the first-stage study at the AIDS Vaccine Conference in Bangkok. Early analysts of the initial data revealed a strong cell-mediated immune response for both the gag and env antigens encoded by the prime and boost agents, the company said. All patients in the study showed anti-env CD+ T-cell immune responses, and Inovio CEO Dr. Joseph Kim said the company believes a 100% vaccine induced env-specific t-cell immune response result has never before been achieved in HIV vaccine trials. "We are pleased to see the response rate and magnitude of T-cell responses generated by the prime-boost vaccine combination," Kim said in a statement. The study is being conducted by the U.S. Military HIV Research Program and is being sponsored by the National Institute of Allergy and Infectious Diseases.

An Indian HIV vaccine that gave encouraging results in the first phase of clinical trial is being given a silent burial with the International AIDS Vaccine Initiative now claiming (IAVI) that the vaccine would not be fully stable in commercial production. However, sources close to the vaccine development alleged that the vaccine was 97 per cent stable way back in 2002 and the rest could have been worked out had the IAVI paid more attention to the indigenous vaccine. IAVI has refuted the charge point blank. The vaccine based on the common Indian strain of HIV was developed through a collaboration between Indian Council of Medical Research and National Institutes of Health USA. The vaccine was then manufactured by US company Therion Biologicals. After successful animal studies in mice and rabbits, the vaccine was put through two rounds of phase-I clinical trials between 2006 and 2009. In the first trial, it was tried alone and second time in a prime-boost mode with another DNA vaccine. Data available with Deccan Herald shows that in the first trial at Tuberculosis Research Centre in Chennai, "The vaccine (TBC-M4) appears to be very immunogenic (generating immune response against HIV) at both low and high doses. The magnitude of the response, although modest, is persistent." The vaccine was found safe for human use as well. Buoyed by the success, a second trial was planned at the TRC and National AIDS Research Institute, Pune, with ADVAX-DNA as the prime vaccine and TBC-M4 as booster. Two groups of 12 volunteers each were shot with the two vaccines. It was found HIV-specific response was 4-8 times higher in those who received both prime vaccine and the booster dose rather than those who were inoculated with the Indian vaccine alone... Despite positive results, IAVI decided not to take the vaccine to the next phase because of the vaccine's instability in large scale production. "The vector (MVA) was identified as genetically unstable, suggesting that it would be difficult to predict batch-to-batch consistency of the vaccine for efficacy studies and for commercial manufacturing with this vector (MVA)," said Rajat Goyal, IAVI country director. "Stability issues were not observed in that trial. It is possible that seed stocks at the company had some problems, which was noticed later...

Synthetic amphetamine-type stimulants (ATS) have surpassed heroin and cocaine to become the second-most widely consumed drugs in the world, after marijuana, according to a study released Tuesday by the UN Office on Drugs and Crime (UNDOC). "ATS are attractive to millions of drug users in all regions of the world because they are affordable, convenient to the user, and often associated with a modern and dynamic lifestyle," says the assessment. "Their risks are often underestimated in public perception." Increasingly, those risks include HIV/AIDS. "Injecting ATS use is also growing and increasing the risk of blood-borne diseases such as HIV/AIDS," the report says. "In Thailand, injecting is the second-most common delivery system for ATS, while in New Zealand it is the most commonly injected drug. Injecting use is also now commonplace in some countries in Europe." Also troubling is the emergence of so-called analogue substances, which may be sold as "bath salts" or "plant food." "Highly dangerous and as yet still deemed legal in many countries, these drugs remain widely available over the Internet," UNDOC warned. "The ATS market has evolved from a cottage-type industry typified by small-scale manufacturing operations to more of a cocaine- or heroin-type market with a higher level of integration and organized crime groups involved throughout the production and supply chain," UNDOC chief Yury Fedotov said in a statement. The volume of drugs seized is indicative of the growing problem. The number of methamphetamine pills confiscated by authorities in Southeast Asia grew from 32 million in 2008 to 133 million last year.

George W. Bush is using key components of his widely touted US President's Emergency Plan for AIDS Relief (PEPFAR) program to expand women's health services in developing countries. The public-private partnership - composed of the US State Department, the Susan G. Komen for the Cure organization, UNAIDS, and the George W. Bush Institute - will harness the infrastructure of doctors, nurses, and clinics participating in PEPFAR to screen and treat women for cervical cancer and to conduct breast cancer education. The goal is to reduce the number of cervical cancer deaths by 25 percent in five years in target countries, primarily in sub-Saharan Africa... The partnership's initial investment is $75 million. "One of our strategies is to start small," said Bush. "A real danger for any initiative is to take on too much." Mark Dybul, who ran PEPFAR under Bush, was a driving force behind the partnership start-up. PEPFAR began setting up clinics to screen and treat women for cervical cancer in 2005; currently, 250 sites in 11 countries offer the services. Some $4 million of PEPFAR's annual budget goes to cervical cancer, and Dr. Eric Goosby, global AIDS coordinator under President Obama, said the United States will contribute another $10 million to the partnership over the next five years.

GlaxoSmithKline has announced it will donate $1 million worth of Cervarix, its human papillomavirus vaccine, to the newly launched Pink Ribbon Red Ribbon partnership, which aims to reduce deaths from women's cancers. The gift will make it possible to vaccinate more than 10,000 females against HPV, certain strains of which cause nearly all cases of cervical cancer. GSK also will provide $50,000 to support the program's operations. The partnership is led by the George W. Bush Institute, the US President's Emergency Plan for AIDS Relief, Susan G. Komen for the Cure, and UNAIDS.

China invested more than $18 million in HIV vaccine research and development in 2010, becoming the third largest contributor globally, after the United States and the European Union, according to a report endorsed by UNAIDS. Internationally, HIV vaccine research and development (R&D) funding stood at $859 million last year, $9 million less than 2009, while China increased its spending by nearly $4 million over the same period, said the global report issued jointly by international organizations including AIDS Vaccine Advocacy Coalition (AVAC) and International AIDS Vaccine Initiative. "The long-term nature of vaccine research will require sustained investments globally and more developing countries like China are expected to shoulder more responsibilities," Kevin Fisher, the coalition's policy director said at the 2011 AIDS Vaccine Conference, which opened on Tuesday. Unfortunately, overall global funding for HIV R&D has flattened out since 2000 and some early supporters, such as Canada and Sweden, have cut back, said the report. In the EU, a major contributor, funding has declined by 23 per cent since 2007. In contrast, the Chinese government has pledged to further boost funding for HIV vaccine development by at least 20 percent in five years, according to Shao Yiming, director of the virology and immunology department of the National Center for AIDS/STD Control and Prevention. Currently, China has four major HIV vaccine candidates under development on the mainland, all financed by the government.

Norwegian biotech Bionor Pharma has released results from a study of its therapeutic HIV vaccine, Vacc-4x. After initially planning to shelve the vaccine last October, the company is now plotting three more studies. The move comes with new evidence showing the jab lowered patients' viral loads and negated the need for antiretroviral therapy. In the study, participants received either 6 shots of Vacc-4x in addition to their antiretroviral pill regimen or a water injection with the pills. Vacc-4x kept 30% of patients off antiretroviral drugs for over a year after treatment, while only 18% of those receiving the placebo experienced the same result, according to the company. Also, 70% of participants receiving Vacc-4x had lower viral load levels 6 months post-treatment, an effect not seen in the placebo group. The vaccine targets p24, a common capsid protein between multiple HIV strains. "We don't see this as a standalone alternative to antiretroviral therapy," Vidar Wendel-Hansen, Bionor's chief medical officer, told Bloomberg. "What we do see is the long-term potential to train the immune system to take over the role of antiretroviral therapy. That's the goal." Bionor and Celgene plan to fund a Phase I/II study studying Vacc-4x with Revlimid to see if the cancer drug enhances the vaccine's efficacy.

The passage of a patent-reform bill by the US Senate on 8 September was a rare win for President Barack Obama, who on the same day gave a high-profile speech on job creation and argued that patent reform was part of the solution. The America Invents Act, as it is called, is also good news for researchers and their institutions. The link to jobs is speculative, but the bill is likely to simplify life for inventors. Most significantly, it moves the United States to a first-to-file system, in which patents are granted to those who get their applications to the patent office first. That should eliminate the lengthy administrative procedures that are often required to determine who has the true priority on inventions under the current first-to-invent system... The bill is also expected to reduce costly patent litigation by ensuring, through a review procedure after the patent is granted, that all patents describe working inventions. 'Patent trolls' -- individuals and companies who attempt to make money by filing broad patents, then suing those who use similar technologies -- will not welcome the move, but legitimate inventors will. A third important change is a presumption that the US Patent and Trademark Office will, at Congress's discretion, be able to keep the filing fees that it raises each year, rather than see them diverted to other parts of the government. That will leave the office with extra resources to clear its backlog of patent applications.

An earlier version of the bill would have prevented Congress from diverting the funds at will, but that provision was watered down by politicians keen to retain congressional control of the budget. The bill also misses an opportunity to loosen constraints placed on research and medicine by gene patents. Researchers or companies who independently develop diagnostic tests based on genes that have already been patented risk being sued for patent infringement... The committee strongly recommended exemptions for anyone conducting independent tests or basic research. An amendment to the America Invents Act could have implemented such exemptions, but now the bill merely calls for yet another study of the issue. Still, the bill's passage with bipartisan support is a precious exception to the polarization that has characterized US political debates as campaigns for the 2012 presidential election get under way. Given that attempts to update the US patent system have failed repeatedly in recent years, researchers should be happy to see reform implemented at last.

Abstract
Context: Most sexual health interventions focus on heterosexual sexual risk behavior. Health practitioners face a lack of information about the sexual health of sexual minority young adults (aged 18-26).

Methods: Three indicators of sexual minority status (identity, behavior and romantic attractions) were assessed in 10,986 young adults who participated in Wave 3 of the National Longitudinal Study of Adolescent Health (2001-2002). Logistic regression analyses examined associations between these indicators and individuals' perceived risk for STDs and actual infection with STDs. Data from the 1,154 respondents who had current or recent bacterial STDs were investigated further to determine whether they had underestimated their risk.

Results: Outcomes varied by sexual minority status indicator and by sex. Bisexual females had significantly higher odds of STDs than heterosexual females (odds ratios, 1.4), and females attracted to both sexes had significantly higher odds of STDs than females attracted only to males (1.8). In contrast, none of the sexual minority status indicators predicted STDs for males. Among respondents who had an STD, females who reported only same-sex sexual relationships were more likely to believe they were at very low risk for STDs than were females reporting only opposite-sex sexual relationships (17.2); homosexual females had a higher likelihood of this outcome than heterosexual females (19.7).

Conclusion: Health practitioners need to assist sexual minority young adults, particularly females, in under-standing their risk for STDs and in taking safer-sex precautions.

Context: Little is known regarding bisexual men's number of recent sex partners, a risk factor for HIV and other STDs. Furthermore, it is unclear if bisexual men have more partners than heterosexual or homosexual men, and whether partner number varies by measures of sexual behavior, identity and attraction.

Methods: Sexual orientation--defined separately by sexual behavior during the past year, identity and attraction--was assessed for 3,875 sexually active men aged 15-44 who had participated in the 2002 National Survey of Family Growth. Chi-square and t tests examined differences in background characteristics, behavioral risk factors and number of past-year sex partners by sexual orientation according to each definition. Multivariate ordinary least-squares regression was used to assess predictors of the number of partners.

Results: When sexual identity and attraction were controlled for, behaviorally bisexual men were predicted to have had 3.1 more past-year partners than behaviorally heterosexual men and 2.6 more than behaviorally homosexual men. After controlling for sexual identity and behavior, bisexual-attracted men had had 0.7 fewer partners than homosexual-attracted men. In a model including background characteristics and behavioral risk factors, behaviorally bisexual men were predicted to have had 2.5-2.6 more partners than others. Neither bisexual identity nor bisexual attraction independently predicted the number of recent partners.

Conclusion: The way in which bisexuality relates to men's number of recent sex partners depends on how sexual orientation is measured. Interventions to reduce behaviorally bisexual men's number of partners will likely lessen their risk for HIV and other STDs.

Vaccines have made a major contribution to global health in recent decades but they could do much more. In November 2011, a Royal Society discussion meeting, 'New vaccines for global health', was held in London to discuss the past contribution of vaccines to global health and to consider what more could be expected in the future. Papers presented at the meeting reviewed recent successes in the deployment of vaccines against major infections of childhood and the challenges faced in developing vaccines against some of the world's remaining major infectious diseases such as human immunodeficiency virus (HIV), malaria and tuberculosis. The important contribution that development of more effective veterinary vaccines could make to global health was also addressed. Some of the social and financial challenges to the development and deployment of new vaccines were reviewed. The latter issues were also discussed at a subsequent satellite meeting, 'Accelerating vaccine development', held at the Kavli Royal Society International Centre. Delegates at this meeting considered challenges to the more rapid development and deployment of both human and veterinary vaccines and how these might be addressed. Papers based on presentations at the discussion meeting and a summary of the main conclusions of the satellite meeting are included in this issue of Philosophical Transactions of the Royal Society B.

A negative human papillomavirus test result was associated with a low long-term risk for cervical cancer, whereas persistent detection among normal cytological women significantly increased the risk. Researchers, therefore, recommend repeat testing after an initial positive test. "In women older than 30 years who test positive for HPV, it is helpful to perform a repeated HPV test 2 years later to improve the predictive value and specificity of cervical cancer screening," the researchers wrote. "The accumulated evidence suggests that it is time to include HPV testing in cancer screening programs for the general population. HPV-negative women will obtain superior reassurance of reduced risk." For the 16-year prospective study, Chien-Jen Chen, ScD, of the Genomics Research Center of Academia Sinica in Taipei, Taiwan, and colleagues examined the role of genotype-specific HPV persistence in predicting cervical cancer, including invasive cervical cancer and carcinoma in situ... We confirmed the critical role of persistent carcinogenic HPV infections in predicting risk of subsequent cervical neoplasia in women aged 30 years and older," the researchers wrote. "The incidence of [invasive cervical cancer] or [carcinoma in situ] following baseline infection by the 12 carcinogenic HPV types was 0.37% per person-year, which was more than 20-times the risk in HPV-negative women. The extraordinary risk stratification of cervical cancer provided by HPV testing in this cohort supports the usefulness of HPV testing, at long intervals, for cervical cancer screening."

U.S. scientists have developed a strain of green-glowing cats with cells that resist infection from a virus that causes feline AIDS, a finding that may help prevent the disease in cats and advance AIDS research in people. The study, published on Sunday in the journal Nature Methods, involved inserting monkey genes that block the virus into feline eggs, or oocytes, before they are fertilized. The scientists also inserted jellyfish genes that make the modified cells glow an eerie green color -- making the altered genes easy to spot. Tests on cells taken from the cats show they are resistant to feline immunodeficiency virus, or FIV, which causes AIDS in cats. "This provides the unprecedented capability to study the effects of giving AIDS-protection genes into an AIDS-vulnerable animal," Dr. Eric Poeschla of the Mayo Clinic in Rochester, Minnesota, who led the study, said in a telephone interview. Poeschla said that besides people, cats and to some extent, chimpanzees, are the only mammals that develop a naturally occurring virus that causes AIDS. "Cats suffer from this all over the world," he said. Just as the human immunodeficiency virus, or HIV, does in people, FIV works by wiping out infection-fighting T-cells. FIV infects mostly feral cats, of which there are half billion in the world, Poeschla said. It is transmitted by biting, largely by males defending their territory, but companion cats are affected as well. In both humans and cats, proteins called restriction factors that normally fight off viral infections are defenseless against HIV and FIV because the viruses evolved potent counter-weapons. But certain monkey versions of these restriction factors are capable of fighting the virus and the team used one such gene from the rhesus monkey. For the team, which included collaborators in Japan, the trick was to get the monkey gene for the restriction factor -- known as TRIMCyp -- into cats to block cells from becoming infected with the virus. To do that, they used a harmless virus to insert the genes into the eggs, a process that has already been done in other mammals including mice, pigs, sheep and marmoset monkeys. To make it easier to check which cells had the monkey gene, the team also inserted a green fluorescent protein gene from the jellyfish Aequorea victoria that makes them glow green. "We did it to mark cells easily just by looking under the microscope or shining a light on the animal." The method worked so well nearly all offspring from the modified eggs have the restriction factor genes. And these defense proteins are made throughout the cat's body. The team has mated two of the three original green-glowing cats, which have produced litters totaling eight kittens which make glowing cells as well...

Two doses of a bivalent vaccine against human papillomavirus (HPV) appeared just as effective in preventing persistent infections as the recommended three doses in young women, according to a study in Costa Rica. In fact, the study -- led by researchers at the U.S. National Cancer Institute -- found that a single dose was effective as well, although the number of participants in that arm was relatively small. The findings were important because, in low-income regions, providing the full three-dose regimen of HPV vaccines to all eligible women and teens may not be economically feasible, explained Aimee R. Kreimer, PhD, of the NCI's epidemiology division in Rockville, Md., and colleagues. "The cost and logistical difficulties of the standard three-dose vaccine regimen compromises implementation of this life-saving measure in resource-poor settings," the researchers wrote online in the Journal of the National Cancer Institute. "Our clinical efficacy data provide suggestive evidence that an HPV vaccine program that could vaccinate 50% more women with a two-dose regimen could potentially reduce cervical cancer incidence more than a standard three-dose program that uses the same number of total doses but in fewer women."

The study was designed as a randomized trial involving nearly 7,500 women, who were to receive either three doses of the bivalent Cervarix vaccine active against HPV serotypes 16 and 18 or a hepatitis... But some participants missed scheduled doses -- 929 ended up receiving only two doses and 551 had just one dose... The most common reason for missing doses was pregnancy, followed by missed appointments and medical conditions. Kreimer and colleagues expressed surprise at the apparent efficacy of a single vaccine dose... The researchers also cautioned that the efficacy rate calculated for the single dose was based on a relatively small sample (only 10 participants receiving one dose of the control vaccine developed persistent HPV infections) and follow-up lasted only about four years. Other limitations of the study included that it was not randomized for fewer than three vaccine doses, that the persistent infection endpoint might or might not translate to protection against the development of cervical intraepithelial neoplasia, and that the study was not performed in younger girls. Experience in other HPV vaccine trials has suggested that the products give protection with less than the full recommended series, Kreimer and colleagues noted. Still, they suggested it would be premature to recommend less than three doses of the bivalent product for all recipients. The full regimen "may confer greater cross-protection against heterologous HPV types," they wrote, and the study results may not apply to other populations or to other vaccine products. "Finally, the duration of protection for fewer than three doses must be quantified," Kreimer and colleagues wrote. They indicated that an ongoing trial in India, sponsored by the WHO, may help settle some of these issues...

Clinical trial data are starting to pour in demonstrating that the HIV prevention strategy known as 'pre-exposure prophylaxis' is an effective way of keeping people at high risk of infection disease free... [H]ealth policy experts and economists are now debating how best to roll out the strategy to those who might benefit most. Preliminary analyses, experts say, indicate that PrEP should be a cost-effective tool to address the HIV epidemic until more testing and treatment for the disease becomes available. Last year, even before PrEP was known to be effective for heterosexuals, a team led by Carel Pretorius of the Futures Institute, a global health think tank based in Glastonbury, Connecticut, published a mathematical model assessing the resources needed to apply it. The analysis concluded that administering PrEP to young South African women could--in an optimistic scenario--prevent up to a quarter of all new cases of HIV in the targeted high-risk age group at a cost of as little as $12,500 per each averted infection. The model asserts that this constitutes a worthwhile investment, as long as the reach of antiretroviral treatment for HIV-positive individuals remains low in the country (PLoS ONE 5, e13646, 2010).

In a similar vein but using a different cost metric, Rochelle Walensky, from Harvard Medical School in Boston has unpublished evidence showing that each year of life saved due to PrEP among a comparable South African cohort should cost just $3,600 when taking into account all downstream survival benefits and costs. That price would be considered by the World Health Organization to be "very cost-effective" since it falls well below the country's average annual per capita gross domestic product... In certain settings, PrEP can cost around $250 per year for a full dose of daily pills and the associated HIV testing and laboratory monitoring. That may sound cheap, but, given shrinking global health budgets around the world, researchers worry about whether the pills will find their way to those who need them most. "Things can be cost effective and even cost saving, but you've still got to find a big lump of cash," says Timothy Hallett, who studies resource allocation for HIV at Imperial College London. Even with adequate funding, however, experts emphasize the moral imperative to assure access to medications for people known to carry the virus before giving limited drug supplies to those not yet infected. "I don't see how we could treat uninfected people without first treating infected people," says Arleen Leibowitz, a health economist at the University of California-Los Angeles. But, outside the developing world, Leibowitz thinks that those willing to pay out of pocket for the drugs should have that option...

Abstract
Background: Pre-exposure prophylaxis (PrEP) trials are evaluating regimens containing tenofovir-disoproxil fumarate (TDF) for HIV prevention. We determined the baseline prevalence of low bone mineral density (BMD) and the effect of TDF on BMD in men who have sex with men (MSM) in a PrEP trial in San Francisco.

Methods/Findings: We evaluated 1) the prevalence of low BMD using Dual Energy X-ray Absorptiometry (DEXA) in a baseline cohort of 210 HIV-uninfected MSM who screened for a randomized clinical trial of daily TDF vs. placebo, and 2) the effects of TDF on BMD in a longitudinal cohort of 184 enrolled men. Half began study drug after a 9-month delay to evaluate changes in risk behavior associated with pill-use. At baseline, 20 participants (10%) had low BMD (Z score less than or equal to -2.0 at the L2-L4 spine, total hip, or femoral neck). Low BMD was associated with amphetamine (OR=5.86, 95%CI 1.70-20.20) and inhalant (OR = 4.57, 95%CI 1.32-15.81) use; men taking multivitamins, calcium, or vitamin D were less likely to have low BMD at baseline (OR=0.26, 95CI 0.10-0.71). In the longitudinal analysis, there was a 1.1% net decrease in mean BMD in the TDF vs. the pre-treatment/placebo group at the femoral neck (95%CI 0.4-1.9%), 0.8% net decline at the total hip (95%CI 0.3-1.3%), and 0.7% at the L2-L4 spine (95%CI -0.1-1.5%). At 24 months, 13% vs. 6% of participants experienced >5% BMD loss at the femoral neck in the TDF vs. placebo groups (p=0.13).

Conclusions: Ten percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures.

Abstract
Background: Intrauterine device (IUD) use has been shown to reduce the risk of endometrial cancer, but little is known about its association with cervical cancer risk. We assessed whether IUD use affects cervical human papillomavirus (HPV) infection and the risk of developing cervical cancer.

Methods: We did a pooled analysis of individual data from two large studies by the International Agency for Research on Cancer and Institut Catala d'Oncologia research programme on HPV and cervical cancer; one study included data from ten case-control studies of cervical cancer done in eight countries, and the other included data from 16 HPV prevalence surveys of women from the general population in 14 countries. 2205 women with cervical cancer and 2214 matched control women without cervical cancer were included from the case-control studies, and 15 272 healthy women from the HPV surveys. Information on IUD use was obtained by personal interview. HPV DNA was tested by PCR-based assays. Odds ratios and 95% CIs were estimated using multivariate unconditional logistic regression for the associations between IUD use, cervical HPV DNA, and cervical cancer.

Findings: After adjusting for relevant covariates, including cervical HPV DNA and number of previous Papanicolaou smears, a strong inverse association was found between ever use of IUDs and cervical cancer (odds ratio 0.55, 95% CI 0.42-0.70; p<0.0001). A protective association was noted for squamous-cell carcinoma (0.56, 0.43-0.72; p<0.0001), adenocarcinoma and adenosquamous carcinoma (0.46, 0.22-0.97; p=0.035), but not among HPV-positive women (0.68, 0.44-1.06; p=0.11). No association was found between IUD use and detection of cervical HPV DNA among women without cervical cancer.

Interpretation: Our data suggest that IUD use might act as a protective cofactor in cervical carcinogenesis. Cellular immunity triggered by the device might be one of several mechanisms that could explain our findings.

Scientific research may be in decline across the globe because of growing pressures to report only positive results, new analysis suggests. A study by the University of Edinburgh examined more than 4,600 scientific research papers published between 1990 and 2007 and found a steady decline in studies in which the findings contradicted scientific hypotheses. Papers reporting null or negative findings are in principle as useful as positive ones, but they attract fewer readers and citations, so scientific journals tend to reject them. It is acknowledged among scientists that this problem might be worsening, because competition in science is growing and jobs and grants are given to scientists who publish frequently in high-ranking journals. Many researchers, therefore, have speculated that scientists will increasingly pursue predictable outcomes and produce positive results through re-interpretation, selection or even manipulation of data. The study examined research papers in which a hypothesis had been tested, in various scientific disciplines. Over the period studied, positive results grew from around 70 per cent in 1990 to 86 per cent in 2007. The growth was strongest in economics, business, clinical medicine, psychology, psychiatry, pharmacology and molecular biology. The findings, published in Scientometrics, also show that papers reporting positive results are more frequent in the US than in Europe. Dr Daniele Fanelli of the University's Institute for the Study of Science, Technology and Innovation, who led the study, said: "Either journals are rejecting more negative results, or scientists are producing more positives. It is most likely a combination of both. "Without negative evidence in the literature, scientists might misestimate the importance of phenomena and waste resources replicating failed studies. The higher frequency of US papers reporting positive findings may suggest that problems linked to competition are greater in the US than elsewhere."

One in 10 gay and bisexual men aged 18 to 21 became infected with HIV during their first year of enrollment in a cohort study in Bangkok. The rate of new infections slows down a bit after that, in part because those most likely to become infected already are. Fully 1 in 3 of them carry the virus by thetime they reach 30. "From 18 to 21 it has been a slaughterhouse," says Frits van Griensven, shaking his head in dismay. "They are getting the best prevention information possible, counselling every four months, condoms and lubricants. They know the facts of incidence of new infections." And yet the infections continue to occur, "It is something that we cannot control with behavioural interventions." Van Griensven runs what is believed to be the only HIV prevention clinic in all of Asia that was created to serve men who have sex with men. This is despite the fact that in Asia, that group is 18.7 times more likely to become infected with HIV than the general population. "It's my opinion that the epidemic in young men is driven by methamphetamines -- crystal ice. I don't know what to do about it," he says. He is not alone. The drug has been a major factor in the spread of HIV among gay men in the US and Europe, though its use seems to be receding because of educational campaigns and because other drugs have become more chic to use.

Rather than adopt a harm reduction approach, the Thai government has taken the approach favoured by most governments, namely a "war on drugs," and it is having the same lack of success... Thailand is not a particularly young country -- the median age is about 34 compared with 25 for India and 40 for the UK -- but the popular culture and street life is very youth oriented. Sexuality is not fettered by restrictions of the monotheist religions of the west, and translational sex -- a kind of monetary equivalent of the sexual "friends with benefits" of the west, rather than prostitution where sex work is a principle source of income -- is a broadly accepted part of life. Young people are the early adaptors of western fashion, music, and electronics and they have shaped a Thai twist to what has become a global youth culture. Sex has driven the broad popular adoption of many technologies in the post-World War II period, including use of the internet. The Thai government has tried to control this but has had the same limited success as most of the other governments that have tried the same task. Much of the drug use and risky behaviour "is being arranged online and practised offline," says van Griensven. That can range from one-on-one sexual encounters to large dance and/or sex parties. "At any time there are probably 40-50 video channels online with thousands of young Thai gay men" talking about sex, ya ice, and other drugs like Viagra. The focus is on action "and there is no talk of HIV prevention or risks. Five years ago you wouldn't see anything about crystal or having sex while high but now it is everywhere. They are soliciting sex with people high on drugs." The DJs on those channels keep the conversation going but they haven't been recruited to help the task of HIV prevention. Nor have the owners of these sites, who profit from the advertising.

Modeling the impact of RV144-like vaccines on HIV transmission
Hankins CA, Glasser JW, Chen RT

Preparing for the availability of a partially effective HIV vaccine: Some lessons from other licensed vaccines
Chen RT, Hu DJ, Dunne E, Shaw M, et al.

The potential impact of an HIV vaccine with limited protection on HIV incidence in Thailand: A modeling study
Nagelkerke NJD, Hontelez JAC, de Vlas SJ

Expected epidemiological impacts of introducing an HIV vaccine in Thailand: A model-based analysis
Schneider K, Kerr CC, Hoare A, Wilson DP

The potential impact of a moderately effective HIV vaccine with rapidly waning protection in South Africa and Thailand
Andersson KM, Stover J

The potential impact of RV144-like vaccines in rural South Africa: A study using the STDSIM microsimulation model
Hontelez JAC, Nagelkerke N, Barnighausen T, Bakker R, et al.

The potential impact of an HIV vaccine with rapidly waning protection on the epidemic in Southern Africa: Examining the RV144 trial results
Andersson KM, Paltiel AD, Owens DK

The cost-effectiveness of a modestly effective HIV vaccine in the United States
Long EF, Owens DK

Expected epidemiological impact of the introduction of a partially effective HIV vaccine among men who have sex with men in Australia
Gray RT, Ghaus MH, Hoare A, Wilson DP

Selectively willing and conditionally able: HIV vaccine trial participation among women at "high risk" of HIV infection
Voytek CD, Jones KT, Metzger DS

Socioecological influences on community involvement in HIV vaccine research
Frew PM, Archibald M, Hixson B, del Rio C

By focusing on HIV's envelope protein and targeting immature B cells--which the virus homes in on--researchers have found a new approach for potential vax candidates. The researchers--from Duke University Medical Center, Beth Israel Deaconess Medical Center and Harvard Medical School--created an envelope protein that attached to B cells better than HIV's own outer coating. "Roadblocks thrown up by HIV have plagued HIV vaccine development," said Hua-Xin Liao, co-senior author of the study, in a release. "HIV hides its Achilles' heels of vulnerability on its outer coat by covering them with sugars. This covering is the result of virus mutations as the virus became resistant to antibodies." The scientists removed many sugars from the protein, and the resulting vaccine showed good immune responses in rhesus macaque trials. It's the first time an altered envelope protein has had a better immune response and attached to the immature B cells better than the virus itself. "This is an important step forward," said Nelson Michael, director of the Military HIV Research Program at the Walter Reed Army Institute of Research, in a release. "The observation that improving envelope immunogen binding to immature B cell receptors can improve immunogenicity provides new hope for design of strategies for inducing difficult-to-induce neutralizing antibodies."

After decades of dashed hopes, AIDS vaccine developers are allowing themselves some cautious optimism. At a conference this week in Bangkok, Thailand, scientists reported molecular clues that help to explain the first-ever success of an HIV vaccine trial in humans. The results could point the way forward for designing future vaccines... The study analyzed clinical samples from a previous HIV vaccine trial of more than 16,000 people that has been dubbed the 'Thai trial' but is officially called RV144. In 2009, scientists leading that trial reported that, after three years, people who received the vaccine were about 30 percent less likely to contract HIV than those who got a placebo1. The modest results marked the first successful human trial of an AIDS vaccine, two years after the high-profile failure of a vaccine produced by the pharmaceutical company Merck. But Thai trial results also left many researchers scratching their heads.

The vaccine regimen consisted of two components that had each failed on their own: a primer vaccine called ALVAC-HIV vCP1521 from Sanofi Pasteur of Lyon, France, containing several HIV proteins, followed by a booster called AIDSVAX from VaxGen of Brisbane, Australia, made of a protein on HIV's surface. Moreover, two of the three measures the researchers used to determine whether the vaccine prevented HIV infection did not reveal differences between vaccinees and controls that reached statistical significance... In the latest study, researchers involved with the trial at Mahidol University in Bangkok and the U.S. Military HIV Research Program in Washington DC assembled a team to scour the blood of trial participants for immune indicators that differed between 41 people who received the vaccine and contracted HIV and 205 participants who did not become infected. Their work isn't complete, but so far the team has found two molecular clues to explain why the vaccine prevented HIV for some but not others. Subjects whose blood contained a Y-shaped immune molecule called an immunoglobulin G (IgG) antibody that recognises a portion of a HIV's outer envelope called the V2 loop were 43 percent less likely to become infected with HIV than subjects whose immune systems did not make these antibodies.

Meanwhile, participants who churned out another kind of antibody, called IgA, that recognises different parts of the HIV envelope fared worse in the trial -- they were 54 percent more likely to become infected than people who did not make these antibodies. However, this immune reaction did not make people more susceptible to the virus than trial participants who got a placebo. The researchers are still studying these results. But Nelson Michael, director of the U.S. Military HIV Research Program, says they reassure him that the vaccine did protect some participants from HIV and that its success was not a statistical fluke... Other research presented in Bangkok support the idea that attacking the V2 loop may be one way to defeat HIV. Viruses collected from the RV144 participants who became infected with HIV possess mutations in this region, suggesting the V2 loop was being targeted by the immune system, Michael says. Meanwhile, tests of a different vaccine in monkeys suggest that animals who make antibodies that recognize the V2 loop tend not to succumb to SIV, a virus related to HIV that infects monkeys.

Today, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) announced awards for a new initiative totaling $45 million over four years to examine the effectiveness of combination approaches to HIV prevention. These evaluations of combination prevention will be the largest and most robust to date. Data gathered will help partner countries to strengthen their efforts to prevent new infections and save lives. To quickly build an evidence base, PEPFAR will support three awards.

With funding from the National Institutes of Health (NIH), the London School of Hygiene and Tropical Medicine will partner with the NIH-funded HIV Prevention Trials Network to examine a strategy linking household-based HIV testing to universal community-based HIV treatment in Zambia and South Africa. The Harvard School of Public Health will receive funding through the Centers for Disease Control and Prevention to evaluate the impact on HIV incidence of expanding population coverage of an integrated set of HIV prevention interventions in Botswana. Through an existing USAID award, Johns Hopkins University will evaluate the impact of an integrated set of biomedical, behavioral and structural prevention interventions to reduce HIV incidence in the Iringa region of Tanzania.

Funders:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Fogarty International Center (FIC)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)

The NIH, in collaboration with the Office of the Global AIDS Coordinator, invites applications for implementation science projects that will inform the President's Emergency Plan for AIDS Relief (PEPFAR) as they develop more efficient and cost-effective methods to deliver proven interventions for prevention of maternal-child HIV transmission (PMTCT).

Posted Date: September 6, 2011
Earliest Submission Date: January 28, 2012
Letter of Intent Due Date: January 28, 2012
Application Due Date(s): February 28, 2012, by 5:00 PM local time of applicant organization.
Scientific Merit Review: June/July 2012
Advisory Council Review: August 2012
Earliest Start Date(s): December 2012
Expiration Date: February 29, 2012

The Presidential Commission for the Study of Bioethical Issues has released its report on the STD research conducted in Guatemala in the 1940s calling the research "gross violations of ethics." The report is available here. Nature News reports that "A second part of its investigation, due to Obama in December, examines whether current rules are adequately protecting research volunteers."

The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Deadline for Abstract Submission
Authors should submit abstracts no later than 5pm EST time on Thursday 17 November 2011.