18 JUNE 2010, VOLUME 11, ISSUE 21

An international organization of pharmaceutical companies has adopted new guidelines governing the publication of clinical trial results. The policy, announced on 10 June, calls for the industry to publish the results of late-stage, 'phase 3' clinical trials in peer-reviewed journals, regardless of the trials' outcome.

The new guidelines from the International Federation of Pharmaceutical Manufacturers and Associations address mounting criticism of pharmaceutical companies for not fully reporting the results of clinical trials -- particularly those that fail. As a result, researchers looking to analyze all clinical trial results for a given therapy often run up against publication bias: the tendency to publish positive results but not negative ones. One recent study found that less than half of completed clinical trials registered in publicly accessible databases were published in peer-reviewed journals (see 'Publication bias continues despite clinical-trial registration').

The guidelines also address concerns over the use of 'ghost-writers' -- writers or statisticians hired to work on the paper without being credited as an author. Nearly 8% of papers published by either industry or academia in six prestigious medical journals may have used a ghost-writer, another recent study found (see 'Ghosts still present in the medical machine'). The new policy calls for such writers, as well as any potential conflicts of interest they may have, to be acknowledged.

Gilead Sciences Inc. said Friday it joined with statewide AIDS Drug Assistance Programs to help U.S. residents with HIV receive antiretroviral medicines. Foster City-based Gilead (NASAQ:GILD) said budget shortfalls across the country are hitting AIDS Drug Assistance Programs, and the company is taking several actions, including additional discounts and extension of pricing freeze for HIV drugs Truvada, Viread and Emtriva through 2013. Gilead is also expanding eligibility for its patient assistance program and eliminating minimum payment requirements through its co-pay assistance program.

Even though the administration's two major policy reviews on development are missing in action and the U.S. Agency for International Development is still full of senior vacancies, USAID Administrator Rajiv Shah is moving ahead with his promise to give the agency back its capability to think strategically by building an official policy planning staff. "This new bureau, bolstered by the agency's many technical assets, represents an essential step toward achieving President Barack Obama's and Secretary Clinton's vision of regaining USAID's status as a premier development agency," Shah wrote in an email to all USAID employees Monday. For now, Lawrence (Larry) Garber will head up the effort as the acting assistant to the administrator for the brand new Bureau of Policy Planning and Learning. Garber will be one of two deputy assistant administrators in the bureau, Shah said. He has had a long career in development, including as CEO of the New Israel Fund from 2004 to 2009.

Agile Therapeutics pulled the wraps off a $45 million Series B preferred stock financing this morning--the company's first financing round since it landed $17.6 million in 2007. The funding will allow Agile to complete Phase III clinical development and file for marketing approval for its low-dose, weekly contraceptive patch AG200-15. The company will also advance AG1000, its progestin-only contraceptive patch for breastfeeding mothers, into Phase II clinical development.

Thomas Rossi, CEO of the Princeton, NJ-based company, spent 20 years in Big Pharma, first working for SmithKline Beecham and later J&J, before he left to found SansRosa in 2003. That company was sold to CollaGenex just as Rossi took on the CEO spot at Agile. The tiny company's name fits it well. Agile, which has only five employees now but plans to double that as new trials get underway, relies heavily on just a handful of employees with deep experience. They make use of CRO and CMO help in order to carry off big projects while keeping their internal structure lean.

One of our longtime favorite commenters, Yancy Ward, who is himself a researcher, writes a perspicacious argument that the method for patenting molecules in the pharmaceutical industry is creating a bunch of problems:

One thing that I have believed is that the future will/should belong to more combination therapies for a lot of targets hit by small molecules. The last project I worked on almost certainly required a combination drug to have efficacy; or we needed a compound that could hit two or more biological receptors in the same class -- something very difficult or impossible to achieve with high enough activity against all targets. I imagine we are going to discover many more cases like this as we learn more about the human genome and it's biology.

Combination therapies have been developed in the past (see AIDs drugs or cancer treatments, for example -- and doctors and researchers have created ad hoc combinations for decades out of the known pharmacopeia), but they typically are combinations of already approved drugs that have efficacy independent of each other. In the case of my project, it is almost certain that the lead compound will fail in the clinical trials due to a lack efficacy, as has happened at other companies targeting the same receptor or receptors in the same class. If you were going to develop a combination therapy of two NMEs, you must put each compound through the clinic separately, get them approved, and then do the clinical trials again on the combination. And the FDA might deny approval in the individual cases because of a lack of efficacy -- a sort of Catch 22.

A 30 per cent salary hike for Ugandan scientists and US$20 million for Tanzanian research were among the science highlights in the two countries' national budgets for 2010/11. The spending pledges -- unveiled yesterday (10 June) -- go some way to fulfilling promises made recently by the East African countries' presidents to improve conditions for science and technology (see Science R&D enjoys a windfall in Tanzania). In January, Ugandan president Yoweri Museveni promised to raise Ugandan scientists' salaries to "international levels" in the financial year starting on 1 July. Yesterday's budget allocated 18 billion Ugandan shillings (US$8 million) for the boost -- not enough to match salaries in rich countries, but a welcome increase for the country's researchers whose pay is low even by East African standards.

Kenya has set aside an unprecedented 900 million shillings (US$11.25 million) for the first time in its annual budget to purchase life-prolonging antiretroviral (ARV) medication; AIDS activists have welcomed the move but say more needs to be invested.

"It is quite commendable that the government of Kenya has allocated this money, even though we still need much more financial commitment for opportunistic infections like TB [tuberculosis], which is the leading killer for those with HIV," said Everlin Kibuchi, tuberculosis advocacy project manager at the Kenya AIDS NGOs Consortium.

"Going from zero to 900 million [shillings] is a huge step in the right direction," said James Kamau, coordinator of the Kenya Treatment Access Movement. Activists have been petitioning the government for many years to boost funding for HIV programmes.

Finance Minister Uhuru Kenyatta allocated a further $12.5 million to recruit 15 nurses and five public health technicians in each of the country's 210 parliamentary constituencies, with $62,500 per constituency for the expansion of healthcare.

Civil society activists are protesting the closure of a factory that produces the only UN World Health Organization-pre-qualified version of a life-prolonging antiretroviral (ARV) drug for infants. Pharmaceutical giant Bristol-Myers Squibb (BMS), which owns the French factory that produces didanosine, a second-line ARV for babies weighing less than 10kg, will shut down the plant in June 2010, stopping production of the drug until at least February 2011, when regulatory approval of a new United States-based manufacturing site is expected. "Closing this factory means that 4,000-7,000 babies currently enrolled in treatment plans in developing countries through UNITAID [a funding mechanism for HIV treatment] could be left without the medicines they need," said the authors of a letter to BMS chief executive officer Lamberto Andreotti.

Didanosine is the last therapeutic option for these babies, and without it they could die ... there is likely to be a shortage of about 15,000 packs of didanosine 25mg across all UNITAID beneficiary countries between now and when production is expected to resume in April 2011," the letter, published in The Lancet, read. UNITAID, the main buyer of didanosine for distribution to developing nations, issued a statement urging BMS to take all measures to ensure the continued supply of didanosine 25mg and 50mg during the transition of its manufacturing site, so as to avoid interrupting treatment of the children whose lives depend on it.

BMS said unforeseen demand had put a strain on the supply of didanosine, but they had taken steps to ensure uninterrupted supply of the drug until the US factory opened. The product would become available immediately upon regulatory approval of the US site. "We preventively built up inventory to twice the level of 2009 demand," BMS spokeswoman Sonia Choi told IRIN/PlusNews. "We are actively working with procurement agencies to provide didanosine to patients in need, and to ensure minimal disruption."

To read the full text of the letter, published in The Lancet, click here.

Cases of condoms (bundled in packets of eight) were prominently displayed and free for the taking in the women's restrooms at Soccer Stadium for Friday's World Cup stadium, evidence of FIFA's awareness of and commitment to the need to confront the epidemic of HIV/AIDS in the host nation. The "Choice" brand condoms were provided by South Africa's Department of Health, and the packaging included a toll-free number for the AIDS Hotline, as well as a six-panel illustration of proper use and disposal. The issue of condom-distribution at World Cup venues was a flashpoint in the run-up to the tournament, with HIV/AIDS groups accusing FIFA of trying to quash efforts to distribute condoms and educational information about the disease.

The low government investment in reproductive health commodities has resulted in an acute condom shortage. Contraceptives used in controlling unwanted pregnancies include condoms, injectables, pills, interuterine devices and surgical contraception equipment.

But condoms remain the most popular and cheapest means used to check STDs/ HIV and unwanted pregnancies in Uganda. According to Dr. Moses Muwonge, a reproductive health consultant, Uganda had a stock of 12 million condoms in May.

The Government imports about 20 million condoms every month. About 10 million are dispatched by the health ministry every month. While the previous minimum stock level was six months with 12 months being the maximum, it has since been revised to four and six months, respectively because of the bulkiness of condoms.

As football fans from around the world arrived in South Africa to cheer their favourite teams at the World Cup, we must not lose sight of one unwelcome guest -- HIV. Why should we talk about HIV during the World Cup?

Two reasons. First, a celebrated sporting event such as the World Cup can encourage the spread of HIV through the combination of alcohol and unsafe sex. Second, almost 80 babies are born with HIV during the 90 minutes it takes to play a football match. This translates into 430,000 babies infected each year. Because we have the means to stop this tragedy, we must act today.

Football stars and UNAIDS Goodwill Ambassadors Emmanuel Adebayor of Togo and Michael Ballack of Germany have joined forces with UNAIDS to launch a global campaign to prevent babies from becoming infe"ted with HIV. The campaign aims to mobilise the football community to "give AIDS the red card" and eliminate mother-to-child HIV transmission between now and 2014, when the next World Cup is played in Brazil. To date, football captains from a range of countries -- Australia, Cameroon, Cote d'Ivoire, France, Ghana, Greece, Nigeria, Paraguay, Serbia, South Africa and Uruguay -- have signed an appeal committing them to use the power and outreach of football to create an HIV-free generation.

The recently concluded international microbicide conference in the US, left experts a task of finding an effective way to protect everyone from HIV using microbicides. The conference brought together about 1,000 researchers, scientists, advocates and community leaders. One new phenomenon researchers discovered was that the incidence of anal sex was rising among married heterosexual couples.

Several researches found incidences of rectal sexual acts between men and women both in and outside marriage. Apart from men who have sex with men, there was a widespread occurrence of anal sex between husbands and wives and with female prostitutes. Studies in Kenya, Rwanda, Zimbabwe, Nigeria, South Africa, Peru, India and Boston US, revealed that men practice anal sex with women as well as men.

In Nigeria, it was reported that some men claim the vagina becomes too wet and loose and so demand for sex in the rectum. Other acts are a function of innovative romance, where research revealed that some wives also like it if it will please their husbands. In other incidents, couples who want to avoid pregnancy, decide to ejaculate into the anus after sex in the vagina.

Prof. Slim Abdool Karim found that most female sex workers at truck stops in KwaZulu, Natal have ever had anal sex. "The number of women, who said they had had anal sex, has increased from 42.8% in 1996 to 61.3% in 2009." Dr. N. Velduijzen of the International Centre for Reproductive Health, who presented studies of sex workers in Mombasa, Kenya and Kigali in Rwanda, found 4.3% anal sex acts in the 820 sex workers of Mombasa and 5.5% among 800 sex workers of Kigali.

HIV is no longer the death sentence it once was. Today's challenges lie in studying the molecular mechanisms of HIV/AIDS and in making interventions practical -- even where money is tight.

Natural immunity
A tiny fraction of people with untreated HIV never seem to progress to AIDS. These people also tend to carry a gene variant called HLA-B57. Last month, Boston researchers showed that this genetic trait works by helping prime the body's T cells to recognize viral mutations more easily. Figuring out natural immunity could be a step toward a vaccine.

Saving baby
For mother-to-child HIV transmission to be halted, an infant's first antiretroviral dose should come within hours after birth. That's hard for women who deliver far from a clinic. One new solution: a small polyethylene pouch, not unlike a ketchup packet. After giving birth, mom simply pours the contents into her newborn's mouth.

Fifteen years after the female condom was first introduced, very few people even know of its existence. One would think that the silent genocide being perpetrated by holding back this life saving option would have received the attention that it so deserves. In 2008, Thohoyandou Victims Empowerment Programme (TVEP), a rural-based women's rights organisation located in one of South Africa's most under resourced provinces, Limpopo, embarked on a training programme that sought to impart information to village women on the importance and correct use of the Female Condom.

As the only woman initiated tool that has been proven to be effective in the prevention of HIV, STIs and unplanned pregnancies, it seemed clear that this technology should be a key feature of South Africa's response to the epidemic which for years has had a black, female, unemployed face. The training also sought to position Female Condom use as 'sexy' for both women and men, essentially turning the device into a sex toy and winning half of the 'bedroom power battle'.

After training more than 70 women and men on the Social Marketing of the Female Condom, TVEP began to receive complaints from the 'Female Condom Ambassadors'... "Where can we get this Female Condom we are now excited about?"...." The clinic has none, the hospital only gave me three...."

As an organisation that was for the last seven years fairly politically naive, after several calls and enquiries to Government Departments at all levels, we found ourselves having to look at the bigger, more contentious issue of Female Condom Programming in South Africa, that of procurement. Always a sensitive topic in a country plagued by tender irregularities and mismanagement of public funds, we then realised that South Africa's National Strategic Plan (2007-2011) contained provision for the purchase of 425 million male condoms yet only THREE million female condoms!

Researchers with the University of Sydney in Australia say the results of recent research could help them to develop a vaccine for the herpes simplex virus. The results, which were recently published in the Journal of Immunology, showed how skin cells are affected by the virus, which is related to the transmission of human immunodeficiency virus, pharmacynews.com reports.

Cheryl Jones, head researcher and associate professor at the University of Sydney, said herpes simplex virus is a significant disease that can cause great devastation in those who suffer from it."Potentially, we may be on the right track for a new discovery," Jones told pharmacynews.com. "The skin represents a major entry point; therefore understanding how immune cells behave during the infection is of vital importance to researchers trying to find a cure for HSV."

The research was conducted on mice. Results indicated that herpes simplex virus can infect and kill Langerhans cells. These are the immune cell in the top layer of the skin, which should exit the skin to the lymph nodes to trigger a stronger immune response to infection, according to the report.

The Fourth International Conference on Peer Education, Sexuality, HIV and Aids opens at the Kenya capital city of Nairobi from this Wednesday at a time when the country is making significant progress in providing healthcare for all.

The meeting, which will be attended by Peer Educators, trainers , Health Workers, NGOs and Facilitators will be held under the theme: HIV Prevention: Covering New Grounds is organized by national Organization of Peer Educators (NOPE). The meeting comes at time when NOPE is celebrating its tenth anniversary and enjoying the international mandate which was effected in July 2007. The organization develops and market wide array of professional and technical services aimed at addressing health and social needs.

The major topics during three previous international conferences addressed different issues like relationship (2004), care (2006) and stigma (2008). Although significant strides have been made in improving access to HIV AIDS treatment, care and support in most countries, the rate of infection is still high. This calls on government to encourage prevention efforts like behavioral change, counseling and testing to stop new infections.

The punishment is brutal -- three pushups! -- each time one of the children kicks a soccer ball into a cone. It's worse if the child hits a cone again. Three pushups for the entire team. The cones represent HIV-related risks, like multiple partners or drug abuse. This activity teaches a person's behavior has consequences that can affect those around him.

It's part of the curriculum of Grassroot Soccer (GRS), a global organization that educates kids in the world's most HIV-affected countries using sports-themed activities. The most comprehensive GRS project -- including 40 staff members plus local volunteers -- is in South Africa during the World Cup. GRS has been fundraising, attracting sponsors and planning events since South Africa was selected host in 2004. South Africa (population 49 million) has more HIV/AIDS cases (5.7 million) than any country in the world.

"Our goal is to educate as many kids as possible and to raise awareness about HIV/AIDS in South Africa using soccer as the entry point," said Ethan Zohn, co-founder of GRS. "It's still a little bit taboo in South Africa, a little stigmatized. By combining something really cool, like soccer and the World Cup, with HIV/AIDS, we're able to break down those barriers."

Zohn is no stranger to soccer -- or Africa. He played in the United Soccer Leagues and in Zimbabwe before becoming a contestant on Survivor: Africa. He won the $1 million prize, some of which he said went to GRS. During the World Cup, GRS will run programs to educate children about HIV while providing a safe place to play soccer and watch matches. Schools in South Africa are closed for six weeks during the tournament.

There's a scene in Jonathan Harvey's play, Canary, in which two gay men -- one young, one middle-aged -- are about to have sex with each other for the first time. The younger one announces that he is into "BB" -- barebacked sex or sex without a condom. His older conquest is appalled. "What if I'm HIV?" he demands. The younger man shrugs. "So what if you do give me something?" he replies. "I'll just take pills."

Of all the scenes in Harvey's acclaimed drama about homosexual experience over the past five decades this one is attracting the most attention. This is because it epitomises an issue worrying many people within the gay community -- a new complacency about HIV. Many older gay men now believe that some younger ones are blase, even reckless about contracting HIV. There's a significant minority, they believe, who regards it as no more serious than any other sexually-transmitted disease, comforted by the availability of powerful anti-retroviral drugs and the message that it's now a "manageable illness". There are even claims of some men knowingly exposing themselves to the virus thinking it "no big deal". Critics say that health campaigners have been so concerned to destigmatise HIV that they have softened its image.

The Dutch have always had liberal views on sex. They led the world in developing open and frank sex education and were rewarded with one of the lowest rates of teenage pregnancy. But their tolerant nature has now hit the brick wall of religious conviction.

The Royal Dutch Medical Association has officially adopted the view that the circumcision of underage boys is medically unnecessary and violates their human rights. It says the benefits are unproven and the complications underestimated, and advocates a "strong policy of deterrence". No issue divides medical and lay opinion like male circumcision. It may be the oldest and commonest surgical procedure in the world but longevity and frequency are no guarantee of acceptability. So is the Dutch Medical Association's move the beginning of a backlash?

According to the World Health Organisation, about 30 per cent of men worldwide are circumcised. The procedure is more popular in the US (an estimated 65 per cent) than in the the UK (16 per cent) but rates are declining in both countries. Most medical organisations in the West, recognising the strong feelings of parents, have stayed aloof from the issue, observing merely that the surgery is rarely medically necessary. However, an editorial in the New England Journal of Medicine in 2008 highlighted evidence about the protective effect of circumcision against HIV (50 to 60 per cent reduction in transmission) and other sexually transmitted infections, including Human Papilloma Virus (35 per cent reduction) and Herpes Simplex Virus (25 per cent reduction) and called for professional societies to review their policies.

More than 200 men and boys had themselves circumcised in the first government-supported circumcision camp at Eshowe, northern KwaZulu-Natal, at the weekend. The provincial department of health and several non-governmental organisations -- the Reproductive Health Research Unit, Mother Adolescent and Child Health and John Hopkins University supported by the United States Government's Presidential Emergency Plan for Aids Relief -- held the first male circumcision camp at Eshowe's FET College.

Young men between the ages of 14 and 25 years were circumcised. The circumcision camp follows the government's announcement that it will scale up medical male circumcision as part of the comprehensive HIV prevention strategy. The plan is aimed at circumcising 2 million men in the next five years. Women are also encouraged to have their newborn babies circumcised immediately after birth.

A substantial proportion of gay men say they would reduce their condom use if pre-exposure prophylaxis (PrEP) proves to be effective, US investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes. The investigators found that the availability of 80% effective PrEP could reduce inhibitions about unprotected sex. Their results also showed that it could lead men to view unprotected sex as having an acceptable level of risk. "A better understanding of the emergent issues inherent in the provision of PrEP will allow for the development of both individual-level interventions supporting PrEP users and community-level interventions designed to increases awareness and acceptability of PrEP", comment the investigators.

PrEP involves the treatment of HIV-negative individuals with antiretroviral drugs to prevent infection with HIV. Laboratory and animal tests have had promising results. A number of clinical trials using PrEP are currently underway and some results are expected shortly. There is considerable optimism about the impact PrEP could have on the transmission of HIV. However, some have cautioned that the availability of a biomedical method of prevention could lead some individuals to become less reliant on condom use and partner reduction to avoid HIV. It has been suggested that an increase in risky sexual behaviour could undermine the potential benefits of PrEP.

Two psychological mechanisms could lead to PrEP increasing sexual risk taking. The first is "behavioural disinhibition". This means that individuals who desire unprotected sex would view PrEP as a substitute for behavioural control, or condom use. It is also possible that PrEP could lead to "risk compensation". Some individuals may consider that PrEP reduces the risk of HIV transmission to such an extent that they are willing to have unprotected sex when taking PrEP.

Thandiwe has full blown Aids. However, she said she regrets that were it not for the patriarchal society she could not be in the situation that she is in now. Thandiwe said despite the fact that she knew that her husband was promiscuous she did not have the courage to negotiate for safe sex.

"My husband was promiscuous, and the community even identified him as one of the bulls. I knew my husband was promiscuous but I could not move out of the marriage because of stigma attached to divorced women," said Thandiwe. "I was also afraid to ask my husband to put on a condom every time we had sex because culturally it is taboo to do that. I knew about the female condom but I had little information about it. I thought the female condom was for prostitutes," she said. "Even when I became visibly sick I still did not have the courage to go to the local clinic until when it was almost too late."

Thandiwe said most women were getting infected with the HIV virus because of cultural beliefs. Her experience motivated her to form a network with other women to discuss about sexual issues and how women can be empowered to negotiate for safe sex. The network is known as Ngatibatanei and is made out of mainly rural women in rural Nemangwe district in Gokwe. The aim is to allow women to openly talk about sex and discuss safe sex methods without any cultural stigmatisation.

Epidemic, plague, scourge, disaster -- what are they talking about? Sometimes the face of HIV/AIDS looks almost pretty these days, making the horrific scenes from 20 years ago seem almost like nothing more than a bad dream. Gone are the visions of lesion-scarred young men turning into walking skeletons practically overnight, dying in unimaginable pain and misery. In their place we see advertisements of handsome young men enjoying life while taking the latest miracle drug designed to combat HIV and make drug companies gobs of money.

Our gala fundraisers such as the Black Tie Dinner and other events like AIDS Arms LifeWalk -- although noble in purpose -- evoke so much cheer and celebration that the HIV/AIDS prevention message gets blurred. AIDS Arms' website this week features an announcement for "Canine Cool Drool 3" on Sue Ellen's patio June 13 benefiting the organization. It all sounds like a lot of fun, and it's easy to see how young people could become deluded into thinking there is no great risk to themselves or their friends, because they never witnessed the ravages of the AIDS epidemic a quarter-century ago.

That's long been a concern of some HIV activists, and the latest report from the Centers of Disease Control seems to bear that out. "Youth Risk Behavior Surveillance in the U.S. 2009," released June 4 on the CDC's website, reports that 34.2 percent of high school students surveyed revealed they were currently sexually active. Of those, 38.9 percent said they had not used a condom during their last sexual intercourse. That behavior had led to substantial health and social problems from unwanted pregnancies and sexually transmitted diseases, including HIV, according to the CDC report analysis.

The only conclusion to be reached from such a survey's results is that the HIV/AIDS prevention message is failing in the U.S. Young people are not scared enough of becoming horribly sick to protect themselves from an easily preventable -- but thus far incurable -- disease.

The abrupt resignation of Shannon L. Hader leaves the HIV/AIDS Administration without a strong leader at a time when federal agencies are pouring millions of dollars into the District to study its epidemic infection rate, the city prepares to host the massive International AIDS Conference and Mayor Adrian M. Fenty campaigns for reelection. Fenty will face voters in the gay community who want to know why he allowed the popular director to walk away from the agency that addressed what he described as his "Number 1 health priority."

And Fenty's choice of interim director, Nnemdi Kamanu Elias, will have to convince the National Institutes of Health and the Centers for Disease Control and Prevention that the HIV/AIDS Administration can continue to study AIDS in a way that allows them to target and treat people who are infected and those who are at a greater risk of being infected. At the Tuesday news conference at which Fenty sent Hader on her way, he listed Elias's credentials: a medical degree from Yale University, a residency in internal medicine and primary care at the University of California at San Francisco, a master's degree in public health at the University of California at Berkeley and work abroad in the Netherlands and Tanzania.

One after the other, the women entered the doctor's office full of hope and expectation and left with a sense of doom: their pregnancies were confirmed but so was their HIV status -- positive. To them it sounded like a death sentence, for themselves and their unborn babies. No matter how much Mitchell Besser, a gynaecologist who had worked with at-risk pregnant women in California, tried to persuade the women he saw at Groote Schuur Hospital in Cape Town that their status did not spell the end, he could not break through the emotional and psychological barriers wielded by the stigma of HIV.

And then he hit upon an idea -- enlist women who were openly living with HIV and were also new mothers to help break down those barriers and educate other pregnant women. With that mothers2mothers (m2m) was born, in 2001.

Gene Falk, an old university friend of Besser's, joined the group after travelling back and forth to the US, and eventually a six-week stint in Cape Town became "for ever". His business experience proved invaluable.

"Start-ups are similar in any industry - when you have something unique to offer, and there is a large demand and you need to grow the organization, the issues are not very different ... The lessons are transferable," Falk, the executive director and co-founder of m2m, told IRIN/PlusNews.

"We provide the link between the clinic and medical care: meds alone do not equal medical care if the patient doesn't understand what the drugs are for, how to take them, etc. So we go beyond emotional support and link women to the treatment they need, for their own care and that of the baby's too," he said.

The first test of a long-acting vaginal ring loaded with an HIV-preventing drug has begun enrolling women in southern Africa. With no prospects for an AIDS vaccine in the next decade or longer, the AIDS community has high hopes for "microbicides," the general term for substances that kill viruses or bacteria on contact. None of the compounds tested to date, however, has worked, and one of them actually increased a woman's risk of becoming infected.

The new study is the 15th undertaken by the International Partnership for Microbicides, a nonprofit group in Silver Spring that has helped lead the search for a discreet, woman-controlled means of protection.

"This is the one that is most likely to work," Zeda Rosenberg, the head of the organization, said last week at Women Deliver 2010, an international conference on maternal and child health held in Washington.

Elizabeth Mataka, the United Nations special envoy for HIV/AIDS in Africa, said she was "very excited about the prospect" of a long-acting microbicidal ring. She told reporters that its advantage is that "nobody needs to know, nobody needs to agree" when a woman uses it.

Heterosexual intercourse is by far the main mode of HIV transmission in the world, with women at somewhat greater risk than men. Of the 33 million people living with AIDS worldwide, 16 million are women age 15 and older. Two-thirds of HIV-infected people live in sub-Saharan Africa, and 60 percent of them there are women.

The product manufactured by the Silver Spring nonprofit is a silicone ring similar to one used in contraceptive devices such as NuvaRing. It is impregnated with dapivirine, an antiretroviral drug. The drug is released into the vagina over a month, after which it is replaced.

See also Kenya: New technology to help women fight Aids, from 11 June 2010 in Catholic Information Service for Africa (Nairobi), http://allafrica.com/stories/201006111118.html.

U.S. researchers, pharmaceutical companies and government officials say they are making progress in an effort to curb what are called neglected tropical diseases, but that they need more money and outside help. A panel on neglected tropical diseases was held in Washington Thursday.

The president of the Sabin Vaccine Institute, Peter Hotez, said neglected tropical diseases get less attention because they do not kill like malaria, HIV/AIDS or tuberculosis. But he said diseases such as river blindness, roundworm, hookworm and whipworm are very important to tackle as well.  Hotez described them as massive disablers for the world's poorest populations. "These neglected tropical diseases by their chronic long-term disabling effects are actually a stealth reason why the bottom billion cannot escape poverty," he said.

Hotez said research has shown these diseases stunt growth, cause memory loss and also lower IQs of affected children. "These are not only the world's leading health problems in terms of how common they are but they are also the world's leading educational problem. Now we know there is actual evidence that chronic hookworm infection in childhood reduces your future wage earning by almost half," he said.

Unintended pregnancies during East African clinical trials of an HIV vaccine are proving problematic. "One or two women dropping out of a study of 40 people makes a big difference to the data," said Prof Omu Anzala, programme director of the Kenya AIDS Vaccine Initiative (KAVI). "One of the conditions for recruitment in these trials is that women must not be pregnant at the time of recruitment, and must not become pregnant for the duration of the trial. Most of the HIV vaccine trials we do in Kenya are phase one trials and the sample size is generally small." A study by KAVI on the issue was recently published in the East African Medical Journal.

Men and women enrolling in such trials usually receive counselling on what to expect, but women are given additional one-on-one counselling on contraception and offered various options, including sexual abstinence. The KAVI study found that only 39 of the 163 participants in its four clinical HIV vaccine trials since 2001 were women; four of them -- who all chose abstinence as their preferred method of contraception -- fell pregnant, but all reported being coerced into having unprotected sex by their partners. As a result, Anzala said KAVI would no longer accept abstinence as an option for contraception.

New research has found that some lubricants used in anal or vaginal sex can cause damage to those tissues that can leave people more vulnerable to sexually transmitted infections, including HIV. Surprisingly, this is the first time that anyone has even looked at the question of whether basic sexual lubricants can cause damage to rectal tissue. The studies were presented at the Microbicides 2010 conference in Pittsburgh at the end of May.

A decade ago research presented at the first microbicides conference showed that nonoxynol-9 (N-9), a spermicide added to many lubricants to prevent contraception, was extremely toxic to rectal tissue. Later studies demonstrated that it increased the risk of becoming infected with HIV through vaginal sex. The gay community learned to avoid lubes containing N-9, and pressured manufacturers to remove it from most products.

This long overdue study of the lubes themselves put six of the most commonly used products to a series of tests used to evaluate the toxicity of potential microbicides -- products that might protect against HIV and other sexually transmitted diseases. An online survey by International Rectal Microbicides Advocates identified the most popular lubes from among more than 150 brands and variations on the market. It turned out that the most important factor is the osmolality, the amount of salts in the product.

Water-based lubes that were hyperosmolar "were actually damaging the epithelium of the rectal and cervical tissue," said Charlene Dezzutti, the University of Pittsburgh researcher who led the study. "The one that was not hyperosmolar, that didn't have any salts in it, and the silicon-based one, did not show any damage."

The Centers for Disease Control and Prevention (CDC) collects, analyzes, and disseminates surveillance data on HIV infection and AIDS; these data are the nation's source of information on the HIV epidemic. The annual surveillance report, published by the Division of HIV/AIDS Prevention, summarizes information about HIV infection and AIDS in the United States and 5 U.S. dependent areas (this report, formerly known as the HIV/AIDS Surveillance Report, has been renamed the HIV Surveillance Report). HIV surveillance data are used by CDC's public health partners in other federal agencies, health departments, nonprofit organizations, academic institutions, and the general public to help target prevention efforts, plan for services, develop policy, and monitor the HIV epidemic. In accord with CDC's recognition of the changing needs for data and its commitment to meeting those needs, the presentation of 2008 data emphasizes the date of diagnosis of HIV infection or AIDS (diagnosis as of December 31, 2008; reported to CDC as of June 30, 2009). The term HIV/AIDS -- previously used to refer to a diagnosis of HIV infection regardless of the person's AIDS status at the time of diagnosis -- has been replaced with the term diagnosis of HIV infection. The new title of the report -- HIV Surveillance Report -- reflects this change in terminology.

Peptides derived from N-terminal heptad repeat (NHR) of the HIV-1 gp41 are generally poor inhibitors of HIV-1 entry because these peptides tend to aggregate and do not form a trimeric coiled coil. In this study, we have fused portions of gp41 NHR, e.g., N36 or N28, to the T4 fibritin trimerization domain, Foldon (Fd), thus constructing novel NHR-trimers, designated N36Fd or N28Fd, which could be expressed in E. coli cells. The purified N36Fd and N28Fd exhibited SDS-resistant trimeric coiled-coil conformation with improved alpha-helicity compared to the corresponding N-peptides. They could interact with a C-peptide (e.g., C34) to form stable six-helix bundle and possessed potent anti-HIV-1 activity against a broad spectrum of HIV-1 strains. N28Fd was effective against T20-resistant HIV-1 variants and more resistant to proteinase K compared to T20 (enfuvirtide), a C-peptide-based HIV fusion inhibitor. Therefore, N28Fd trimer has great potentials for further development as an affordable therapeutic or microbicide for treatment and prevention of HIV-1 infection.

Background: Myeloperoxidase (MPO), an important element of the microbicidal activity of neutrophils, generates hypochlorous acid (HOCl) from hydrogen peroxide and chloride, which is released into body fluids. Besides its direct microbicidal activity, HOCl can react with amino acid residues and HOCl-modified proteins can be detected in vivo.

Findings: This report is based on binding studies of HOCl-modified serum albumins to HIV-1 gp120 and three different neutralization assays using infectious virus. The binding studies were carried out by surface plasmon resonance spectroscopy and by standard ELISA techniques. Virus neutralization assays were carried out using HIV-1 NL4-3 virus and recombinant strains with CXCR4 and CCR5 coreceptor usage. Viral infection was monitored by a standard p24 or X-gal staining assay. Our data demonstrate that HOCl-modified mouse-, bovine- and human serum albumins all bind to the HIV-1 NL4-3 gp120 (LAV) glycoprotein in contrast to non-modified albumin. Binding of HOCl-modified albumin to gp120 correlated to the blockade of CD4 as well as that of V3 loop specific monoclonal antibody binding. In neutralization experiments, HOCl-modified serum albumins inhibited replication and syncytium formation of the X4- and R5-tropic NL4-3 isolates in a dose dependent manner.

Conclusions: Our data indicate that HOCl-modified serum albumin veils the binding site for CD4 and the V3 loop on gp120. Such masking of the viral gp120/gp41 envelope complex might be a simple but promising strategy to inactivate HIV-1 and therefore prevent infection when HOCl-modified serum albumin is applied, for example, as a topical microbicide.

China faces a rapidly emerging HIV epidemic and nationwide resurgence of sexually transmitted infections associated with a growing sex industry. Community empowerment and capacity building through community-based participatory research partnerships show promise for developing, testing, and refining multilevel interventions suited to the local context that are effective and appropriate to address these concerns. However, such efforts are fraught with challenges, both for community collaborators and for researchers. We have built an international team of scientists from Beijing and the United States and collaborating health policy makers, health educators, and care providers from Hainan and Guangxi Province Centers for Disease Prevention and Control and the local counties and towns where we are conducting our study. This team is in the process of testing a community-wide, multilevel intervention to promote female condoms and other HIV prevention within sex-work establishments. This article presents lessons learned from our experiences in the first two study sites of this intervention trial.

The role individual skin dendritic cell (DC) subsets play in the immune response to HSV remains unclear. We investigated the effect of HSV on DC virus uptake, viability, and migration after cutaneous infection in vitro and in vivo. HSV increased the emigration of skin DCs from whole skin explants over 3 d postinfection (p.i.) compared with mock controls, but the kinetics of emigration was influenced by the skin DC subset. Uninfected (bystander) Langerhans cells (LCs) were the major emigrant DC subset at 24 h p.i., but thereafter, large increases in infected CD103+langerin+ dermal DC (dDC) and uninfected langerin- dDC emigration were also observed. LC infection was confirmed by the presence of HSV glycoprotein D (gD) and was associated with impaired migration from cultured skin. Langerin+ dDC also expressed HSV gD, but infection did not impede migration. We then followed the virus in live MacGreen mice in which LCs express GFP using a fluorescent HSV-1 strain by time-lapse confocal microscopy. We observed a sequential infection of epidermal [gamma][delta] cells, first in keratinocytes and epidermal  T cells at 6 h p.i., followed by the occurrence of HSVgD+ LCs at 24 h p.i. HSV induced CCR7 upregulation on all langerin+ DC, including infected LCs, and increased production of skin TNF-[alpha] and IL-1[beta]. However, a large proportion of infected LCs that remained within the skin was apoptotic and failed to downregulate E-cadherin compared with bystander LCs or mock controls. Thus, HSV infection of LCs is preceded by infection of [gamma][delta] T cells and delays migration.

Editor's note: The July 2010 issue of Current Opinion in HIV and AIDS covers the sexual transmission of HIV. Articles included in this special issue (July 2010 - Volume 5 - Issue 4)  are listed here.

HIV prevention 2010: where are we now and where are we going?
Cohen, Myron S; Fidler, Sarah

Modelling sexual transmission of HIV: testing the assumptions, validating the predictions
Baggaley, Rebecca F; Fraser, Christophe

Role of acute and early HIV infection in the sexual transmission of HIV
Miller, William C; Rosenberg, Nora E; Rutstein, Sarah E; Powers, Kimberly A

Antiretroviral treatment of primary HIV infection to reduce onward transmission
Hamlyn, Elizabeth; Jones, Vicky; Porter, Kholoud; Fidler, Sarah

An overview of the relative risks of different sexual behaviours on HIV transmission
Dosekun, Olamide; Fox, Julie

Highly active antiretroviral treatment as prevention of HIV transmission: review of scientific evidence and update
Granich, Reuben; Crowley, Siobhan; Vitoria, Marco; Smyth, Caoimhe; Kahn, James G; Bennett, Rod; Lo, Ying-Ru; Souteyrand, Yves; Williams, Brian

Contribution of sexually transmitted infections to the sexual transmission of HIV
Ward, Helen; Ronn, Minttu

Sexual risk behaviour for transmission of HIV in men who have sex with men: recent findings and potential interventions
McDaid, Lisa M; Hart, Graham J

Microbicide research: current and future directions
Ramjee, Gita

Postexposure prophylaxis for HIV following sexual exposure
Barber, Tristan J; Benn, Paul D

Identifying and characterizing recently transmitted viruses
Keele, Brandon F

Antiretroviral drug concentrations in the male and female genital tract: implications for the sexual transmission of HIV
Taylor, Stephen; Davies, Sophia.

Male circumcision to reduce sexual transmission of HIV
Templeton, David J

Medical products used in the developed world often fail to adequately serve resource-limited settings where electricity, transportation and health care workers are not readily available. We suggest that the problem is not only a lack of coordinated financial resources to purchase existing medical products, but also a lack of products that are specifically designed for resource-limited settings. While donor organisations with a focus on global health are increasingly willing to bear the additional financial risk for the research and development of such high-impact medical products, corporations are still reluctant to take their best scientists and engineers away from more commercially attractive projects. Universities, on the other hand, given their teaching and research missions, are well positioned to engage in such high-risk development projects. A group of biomedical, engineering, business and social science researchers at Northwestern University (NU) propose a creative model to address significant social and health needs. The team's initial product focus is a rapid test for diagnosing infants with HIV. The NU model aligns the incentives and expertise of industry, donors and academia to innovate medical products, such as the infant HIV diagnostic test, for resource-limited settings.

This update includes information on a series of webinars based on thought-provoking presentations from the International Microbicides Conference (M2010). These webinars, which will take place in June and July, will provide advocates with a grounding in important HIV prevention research topics that will likely emerge at the upcoming XVIII International AIDS Conference (IAC) in Vienna, July 18-23. Each of these webinars will feature a short overview from the M2010 presenter, and the rest of the hour will be devoted to facilitated discussion.

Webinar schedule
Thursday, June 24, 11am-noon ET
Topic: State of the Microbicide Field: Beyond tenofovir and novel non-ARV based approaches
Speaker: Robin Shattock, St. Georg e's University of London, UK

Thursday, July 1, 11am-noon ET
Topic: When Health Care Priorities Collide: ARVs for treatment and prevention
Speaker: Regina Osih, Reproductive Health & HIV Research Unit, South Africa

Monday, July 12, 11am-noon ET
Topic: Interpreting Clinical Trial Results: Preparing for upcoming results
Speaker: Ben Masse, Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, US

(Visit http://www.timeanddate.com/ to confirm the time in your timezone.)

To register for the webinar series, please email your name and country to avac@avac.org. We will circulate links and dial-in information in a reminder email the week of each webinar, so please look out for additional information. Following each installment of the series, you will receive a link to the call recording and slides to download and review at your leisure. All sessions will also be archived on the AVAC website.

Request for Applications (RFA) Number: RFA-DA-11-001 
Purpose. This FOA solicits R01 applications for both domestic and international studies that test the seek, test, treat, and retain paradigm. This paradigm predicts that expanding HIV testing and reducing viral load among HIV+ individuals through HAART therapy can be effective in reducing the HIV transmission at a population level.  In particular, this FOA focuses on research on expanding HAART therapy coverage to reduce HIV transmission among high-risk, vulnerable populations.

Funds Available and Anticipated Number of Awards:  The National Institute on Drug Abuse intends to commit $8 million dollars in FY11 to fund 5-7 new awards and the National Institute of Mental Health will commit $500,000 to fund 1 new award.

Budget and Project Period: Direct costs will vary with the scope of the project and may exceed over $500k per year if warranted by the scope.  A project duration of up to five years may be requested.  

Key Dates
Opening Date: October 15, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 15, 2010

Meeting Dates for 2010:
September 14-15, 2010

Conference Call Dates for 2010:
July 27, 2010 - 1 PM to 2 PM EDT
August 25, 2010 - 1 PM to 2 PM EDT

The Committee meets three times a year in Washington, DC. These meetings are open to the public. Time is allotted at every meeting for public response and comment. Pre-registration is required for both public attendance and comment. Meeting details are posted in a Federal Register notice at least 15 days prior to each meeting. Details regarding comments will be listed in the Federal Register notice for each meeting. If you wish to provide written comments, please submit them at least five business days in advance to nvpo@hhs.gov.

Meeting Site:
Hubert H. Humphrey Building - Room 800
200 Independence Avenue, SW
Washington, DC 20201