The Weekly NewsDigest is a compilation of HIV prevention research media coverage and relevant science in peer-reviewed journals; material on
other reproductive health issues; and matters of policy and politics relevant to HIV prevention research, development and advocacy.
Its purpose is to raise awareness around the range of opinions and information about HIV prevention research disseminated in the press and
scientific journals and provide a neutral, objective basis for decision-making and evidence-based advocacy.
Editor's Note: FHI provided this special compilation of media coverage, articles, and public statements during the period 23-29 July that were specifically related to release at the 2010 AIDS Conference of the results from the CAPRISA 004 trial of the 1% vaginal gel formulation of tenofovir.
In his column published in the Sowetan on 27 July 2010 (see "Research on HIV prevention gel put black lives at risk" below), Andile Mngxitama viciously attacks South African researchers who recently announced a huge breakthrough in the development of a microbicide, a gel that they hope women will be able to use to reduce their risk of being infected with HIV from sex. Under the guise of black consciousness he distorts facts, takes an opinion on something he knows little about, and makes statements that will cause life-threatening confusion. Steve Biko would never have written in this way.
Mr Mngxitama is wrong on every count. Let me set out the facts. The trial he refers to is known as CAPRISA 004. It is the first trial ever to establish that a microbicide reduces the risk of women contracting HIV from sex. Until the trial results were made public, no-one knew if such a gel would offer any protection. Earlier studies had only shown that it was safe to use. Now the scientific world has evidence on the basis of which many women -- especially black women -- may be protected from HIV infection in the future.
The trial did not put black lives at risk. All the women who participated were extensively counselled about HIV prevention. In fact there is evidence that simply participating in a trial reduces the risk of HIV infection. But it is also known that even in trial settings, where participants are freely provided with condoms, lubricant and ongoing HIV counselling, some degree of unsafe sex continues. As a result, after 2.5 years, 11% of trial participants -- and not the 60% Mr Mngxitama claims -- contracted HIV.
Mr Mngxitama asks why the study was not conducted on urban white middle class women. The answer is simple. There is a high prevalence of HIV among black women because of the combination of poverty, sexual and social inequality and illiteracy. It would have been impossible to conduct this study amongst a population that has a relatively low HIV prevalence. The trial participants were chosen because they are part of communities that have been hit particularly hard by HIV. The reality is that many women in South Africa have unsafe sex, often because they are unable to get their male sexual partners to wear condoms. They are fully able to make choices for themselves, but all too often their male partners impose their bad choices on them. It is these women who are most in need of female-controlled prevention tools such as a microbicide.
Mr Mngitxama protests that "none of the women knew who was protected and who wasn't." But a key principle of clinical research is that the only scientifically acceptable way to do determine if a new medicine works is by randomly dividing the trial participants into two. The first group is given the test product. The second group is given what is called a "placebo", something which looks, feels and smells exactly like the product being tested, but without the trial ingredient (medicine) -- in this case the antiretroviral (ARV) medicine tenofovir.
So, all women got gels, but only half of them got gels containing the drug. However each participant was fully counselled about the trial and understood that: (a) There was a 50% chance they had been given the gel (and a 50% chance that they had been given the placebo); (b) There was no evidence that the gel worked; and (c) Even if the gel worked, it would not be 100% effective -- meaning that condoms should also be used consistently and correctly.
Without any evidence, Mr Mngxitama patronisingly suggests that informed consent is "tricky" for vulnerable women. Echoing former President Thabo Mbeki he attacks orthodox science and accuses those who have conducted trials of male circumcision and microbicide gels of "medical science genocide" and of treating blacks "as one would treat an animal".
I could go on and on, but I won't. But let me list two more of Mr Mngxitama's long list of errors and misleading suggestions:
The women who tested HIV positive were not "used as lab rats and discarded" -- they were all directed into care. As and when necessary, they will be able to access ARV treatment.
New prevention technologies are not being targeted at blacks, but rather at all people at high risk of infection. For example, a trial that is currently taking place in Cape Town amongst men who have sex with men is designed to establish whether a daily dose of two ARV medicines can reduce the risk of HIV infection. Many of those participating in the trial are white and middle class.
Finally, there is a good reason why those concerned with medical ethics have not raised their voices about the trial -- it was conducted ethically. The researchers have advanced the struggle against the pandemic in South Africa and beyond. They are African scientists advancing African knowledge from African universities. They are deserving of our praise, not uninformed and dangerous attacks.
Research on HIV prevention gel put black lives at risk 27 July 2010 Sowetan
In fact, talk is that the government is going to take every possible step to make sure the gel is available to women. The "breakthrough" is sold to the public as empowering to women because women can apply the gel without having to consult their sexual partners. There are shocking ethical questions the study raises and I'm told that the medical science fraternity and people who are concerned with ethics have not raised their voices.
For starters, the study was conducted in the most depressed areas. Women who participated in the study can be said to be a "vulnerable group". This means issues of consent become very tricky. Did the women know the full implications of subjecting themselves to the study? Why was the study not conducted in urban areas with white middle-class women? Just imagine this, the study had to find almost a thousand black vulnerable women who are HIV-negative and then wait for a "statistical significant" number of them to become HIV-positive in order to draw conclusions. This callousness and disrespect for black lives is shocking.
The method employed by the study was to recruit the participants and divide them into two groups. One group was given a "blank" gel. In other words, they were not potentially protected, but didn't know. The other group was given the gel with antiretrovirals. The key issue here is that none of the women knew who was protected and who wasn't. This might mean they then altered their sexual practices and thereby exposed themselves to the HI virus. One doesn't need to be a rocket scientist to know that human behaviour is unpredictable and people will go for easy solutions.
But people can also be duped. When the study was finished it was shown that a shocking 60 percent of the women were now HIV-positive. However, the study was declared a great success. The question is, what happened to the women who became HIV-positive? It seems that it's either these women were used as lab rats and discarded, and this was on the basis of the assumption that they were going to be HIV-positive anyway. So the 40 percent that is said to have been "protected" are saved!
No one asked a simple question - if these women were recruited from high-risk HIV areas, how did they stay negative for as long as they did? Would this not have been a more ethical study than subjecting people to such risks? Medical science genocide is allowed against the weak historically, but when the weak are blacks then it doesn't really matter. The idea of a gel that prevents transmission of HIV operates in the same logic of circumcision as HIV prevention methods. These methods are encouraged among blacks. This is because it is assumed that blacks cannot control themselves, so we make them cut pieces of their flesh and insert gels in their bodies instead of education, prevention, treatment and real empowerment. Blacks are treated as one would treat an animal.
The 18th International AIDS Conference was recently held in Austria with delegates from across the world including prominent names such as Bill Gates and former US president Bill Clinton. The conference ended with so many unanswered questions, key among them was the failure by several governments to invest heavily in the right strategies to address HIV/AIDS. Uganda is one of the countries that continue to evade investing in the tested and proven approaches to addressing the scourge. There are over 500,000 people who are at risk of losing their lives to AIDS if they do not access the highly needed ARVs in the coming months. As a country, we have not done much to increase equal access to treatment by availing drugs and fighting stigma and discrimination. Focus on reducing stigma and discrimination increases the number of people who go for testing and treatment. Many people still fear to know their HIV status.
Tachi Yamada was a big name in Big Pharma before he took the top global health job at the world's richest charitable organization, the Bill & Melinda Gates Foundation. But no single organization -- not even a multi-national, multi-billion dollar R&D shop at GlaxoSmithKline, or the Gates Foundation -- can conquer leading killers like HIV, tuberculosis, diarrheal diseases, and malaria by itself. The need for productive partnerships came up over and over again yesterday at an event yesterday at PATH, the nonprofit global health hothouse based in Seattle. This event brought together Yamada, Washington Gov. Chris Gregoire, Helene Gayle of CARE USA, Anne-Marie Slaughter, a high official in the U.S. State Department, and others. Most of the talk was about forming partnerships between the U.S. and other nations, between the state and federal governments, and between nonprofits like PATH, Seattle Biomedical Research Institute, the University of Washington, etc. A number of speakers emphasized the humanitarian need to stay committed to fighting scourges of the developing world, even when state and federal budgets are tight. Yet little was said about how all the nonprofits and governments are supposed to work with Big Pharma companies like Yamada's former employer, or for-profit venture-backed biotech companies whose job it is to turn basic research into actual vaccines, drugs, diagnostics -- and get them implemented in a big way.
Programmes of mass circumcision of men could be scaled up rapidly in poor settings, delegates heard at the 19th international AIDS conference in Vienna last week. Scaling up male circumcision to 80% of adult men and male newborns in eastern and southern Africa by 2015 could avert more than four million new infections of HIV between 2009 and 2025 and could save $20bn (£13bn; 15bn) in that period, experts said.
Krishna Jafa, director of HIV, tuberculosis, and reproductive health at the non-governmental organisation PSI (Population Services International), said, "With global resources spread thin, we must focus on expanding proven and cost effective methods, like male circumcision, to prevent HIV transmission." Her comments echoed calls by Bill Gates and Bill Clinton for cost effective measures to prevent the spread of HIV.
Researchers presented results from a project in South Africa that offers free and safe circumcision to all men aged 15 years or older living in the Orange Farm township, Gauteng province, where the prevalence of HIV among adults is about 15%. The results were published last week in PLoS Medicine (2010;7(7):e1000309, doi:10.1371/journal.pmed.1000309). By November last year 14 011 men had been circumcised.
Research organisations, universities and industry, will receive a sum of 6.4 billion (Euro) next year in the European Commission's largest ever allocation for research and innovation. Research commissioner Maire Geoghegan-Quinn said on Monday (19 July) when presenting the plan that around 16,000 participants, including about 3,000 small and medium businesses, will receive funding. "The investment I am announcing today will create 165,000 jobs over the relatively short term and potentially many many more over the long term," the commissioner told reporters.
The sum represents a 12 percent increase on the 5.7 billion (Euro) that will have been handed out in 2010. Grants will be allocated via calls for applications, some of which are to be issued on Tuesday. Small and medium-sized enterprises will receive close to 800 (Euro) million next year. In total, businesses should also receive at least 15 percent of the total funding. The current rate is around 14 percent, the commission said. Additionally, 35 percent of the total budget is to be ear-marked for certain specific topics including health, biotech, nanotechnology and the environment.
Having met President Obama, I'm confident that he's a man of conscience who shares my commitment to bringing hope and care to the world's poor. But I am saddened by his decision to spend less than he promised to treat AIDS patients in Africa. George W. Bush made an impressive commitment to the international fight against AIDS when he formed the President's Emergency Plan for AIDS Relief program. Since 2004, Pepfar has spent $19 billion to help distribute anti-viral treatments to about 2.5 million Africans infected with H.I.V. Thanks to these efforts -- and similar initiatives, like those spearheaded by the Global Fund to Fight AIDS, Tuberculosis and Malaria -- the number of African patients with access to AIDS drugs jumped tenfold from 2003 to 2008. Since 2004, the AIDS-related mortality rate in sub-Saharan Africa has dropped 18 percent. Yet President Obama added only $366 million to the program this year -- well below the $1 billion per year he promised to add when he was on the campaign trail. (Pepfar's total budget now stands at $7 billion.) Most of the countries in Pepfar will see no increase in aid.
In a plenary speech at here at AIDS 2010: XVIII International AIDS Conference, Bill Gates, cochair of the Bill & Melinda Gates Foundation and nonexecutive chairman of Microsoft, opened by telling the audience that in these times of constrained national budgets and investments in global health, he is still an optimist about fighting AIDS. He cited recent progress, with 5 million people now receiving antiretroviral treatment worldwide, up from fewer than half a million only 6 years ago. The rate of new HIV infections has fallen by 17% since 2001, he said.
He attributed the progress to scientists, clinicians, community workers, advocates, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. During the past 20 years, more than 2 dozen antiretroviral drugs have been developed, many of which are now being made cheaply enough to serve developing nations, and regimens have been simplified, making it easier for people to adhere to them. The challenge now is to come up with funding mechanisms that will allow the progress to continue by treating more people infected with HIV, and thereby also preventing transmission. In this "tough economic environment...there isn't enough money to simply treat our way out of this epidemic," Mr. Gates said. Current spending cannot keep up with the need for treatment, and he called for ways to get more benefit from every dollar spent and each effort expended. With more efficiency in treatment and prevention, including new prevention tools, "We can drive down the number of new infections dramatically and start writing the story of the end of AIDS," he predicted.
Activists and scientists at the International AIDS Conference in Vienna called on governments to stop criminalizing drug users and instead to provide them with addiction and HIV treatment. "Sooner or later, people have to figure out that we're not going to be able to solve the HIV epidemic if we don't address the needs of injecting drug users [IDUs]," Julio Montaner, president of the International AIDS Society (IAS), said in Vienna. "If you want an example of that, you have to go to eastern Europe to see where the worst in injection epidemics is now rapidly becoming a mixed epidemic," he added. Montaner presented evidence from a Canadian study which found that increasing drug users' access to antiretroviral treatment (ARV) could improve health and reduce new infections.
Like its House of Representatives counterpart 2 weeks ago, a Senate subcommittee today matched President Barack Obama's request for a $1 billion increase in 2011 for the National Institutes of Health (NIH). That raise would bring the agency's total budget to $32 billion, or 3.5% above the 2010 level, according to a statement from the Senate appropriations labor, health, and human services subcommittee.
Because the Senate panel had less money to work with in its budget allocation than the corresponding House subcommittee, biomedical research advocates feared the number would be lower. "We're pleased. Given the overall budget situation, it's a very good outcome," said David Moore, senior director for government relations at the Association of American Medical Colleges. Even so, the $1 billion falls far short of the amount that some biomedical groups feel NIH needs to avoid a sharp drop in the number of grants the agency supports next year after the agency's stimulus money runs out.
The bill also contains $50 million for the Cures Acceleration Network, a drug-development program added to the health reform bill earlier this year by Senator Arlen Specter (D-PA). The House panel had approved "up to" $50 million for the new program -- a slight difference that will need to be worked out. It's not yet clear whether appropriators found that money by making a slight cut in the budgets of NIH's 27 institutes and centers. "The $50 million has to come from somewhere," Moore says. Some scientific groups worry that it will come at the expense of investigator-initiated grants.
Both House and Senate bills will go to the full appropriations committees before the two houses meet to work out a compromise bill. A vote on the final bill is not expected until after the November congressional elections.
Ten years ago, many experts thought you couldn't bring antiretroviral therapy to people with AIDS in poor countries. The drugs cost too much, there weren't enough doctors, the patients wouldn't take the medicines correctly, and the risk of creating a resistant virus was too high. None of that turned out to be true. About 5.2 million people with HIV infections are on lifesaving treatment in low- and middle-income countries. In sub-Saharan Africa, antiretroviral therapy, much of it paid for by the U.S. government, is resurrecting whole communities.
But the world is facing a potentially more intractable problem: the price of success. There's barely enough money to pay for people whose treatment is underway and who will need it for a lifetime. There isn't enough to start treatment for about 5 million more who urgently need it. Those new concerns about costs dominated the 18th International AIDS Conference, which drew 19,300 participants from 193 countries to Vienna last week. "If I were to characterize the mood here, I would say it was a combination of rage and panic," said Joanne Carter, director of the anti-poverty group Results and a board member of the Global Fund to Fight AIDS, Tuberculosis and Malaria.
The rage is directed at the Obama administration, which many activists say is reneging on a commitment to continue big annual increases in global AIDS spending. The panic arises from the knowledge that in some African countries, patients who want antiretroviral treatment are being turned away and will soon start dying.
At the 18th International AIDS Conference last week, the South African government -- which from 1999 to 2008 had a president who questioned whether HIV even caused disease and a health minister who advocated lemons and garlic for treatment -- declared that "Today, we are guided by science." Indeed, the news from South Africa was a bright spot in what was otherwise a gloomy discussion of the funding shortfalls that threaten to slow the remarkable progress against HIV/AIDS made during the past 6 years. The sea change in South Africa -- which has an estimated 5.5 million infected people, more than any other country -- was especially welcomed because of a growing sentiment that the hardest hit nations must do more to help themselves.
What if you could use a product -- and not a condom -- to prevent getting infected with HIV? That may feel like a fantasy, but it's actually edging closer to reality. At the XVIII International AIDS Conference in Vienna, Austria, the exciting South African CAPRISA study showed that using a microbicide gel containing an anti-retroviral (ARV) drug before and after sex can prevent HIV in women at least 39 percent of the time. Many believe this good news is a major step in the notion of "treatment as prevention."
"[The CAPRISA study] folds into an even grander dream which is Pre-Exposure Prophylaxis (PrEP), an oral pill that an HIV-uninfected person takes to prevent infection," said Science magazine reporter Jon Cohen, author of that magazine's coverage of CAPRISA and Shots in the Dark: The Wayward Search for an AIDS Vaccine, in an interview on Tuesday. "It's a hugely promising approach because this says if [the microbicide] works, then [PrEP] has a high likelihood of working. And if PrEP works, then we have a whole new way to look at treatment as prevention."
Second-quarter sales of Gilead Sciences Inc's core HIV drugs fell short of Wall Street estimates, and its shares fell 1 percent after-hours on Tuesday. The biotech company also cut $100 million from its 2010 sales outlook, citing currency exchange rates, including a weaker euro. Earlier this year, the forecast had been trimmed by $200 million due to the impact of U.S. healthcare reform. "For HIV, the U.S. business continues to perform very strongly. But the environment in the European union has been challenging," Gilead Chief Executive and Chairman John Martin said during a conference call.
During the global economic downturn, several European countries cut their prices for HIV drugs. Second-quarter sales of AIDS drug Truvada rose 6 percent to $641.7 million, while sales of Atripla, which combines Truvada with Bristol-Myers Squibb Co's (BMY.N) Sustiva into a single pill, rose 26 percent to $715.8 million. Analysts, however, had expected Truvada sales of $675 million and Atripla sales of $725 million, according to Wedbush Securities.
Drugmakers Merck, Tibotec and Gilead are in advanced talks with UNITAID about a patent pool to make AIDS drugs more widely available to the poor, the health funding agency said on Wednesday. But ViiV Healthcare -- a GlaxoSmithKline and Pfizer joint venture company for AIDS drugs and a key player in this market -- does not appear keen to join the pool, a senior UNITAID adviser said. "ViiV is, I would say, the least interested in making this work," Ellen 't Hoen, an expert on intellectual property at UNITAID told reporters at an international conference on AIDS in Vienna. "We had expected a bit of a warmer reception."
GSK, the majority partner in ViiV, has in the past agreed to join patent pools on malaria and neglected diseases, but has always stopped short of offering to pool patents on medicines for HIV/AIDS, which it does not consider a neglected disease. ViiV said last week it was opening its entire AIDS product line-up for licensing agreements with generic drugmakers who sell to 69 of the world's poorest countries where 80 percent of all those with HIV live.
Gay and bisexual men didn't have riskier sex or suffer serious side effects while using Gilead Sciences Inc.'s Viread in a study of whether taking pills to prevent HIV infection would loosen inhibitions or harm health. Gay and bisexual men who took a daily pill -- either Viread or a placebo -- were no more likely to take greater sexual risks on the assumption they were protected than those who didn't take one, researchers from the U.S. Centers for Disease Control and Prevention said at the International AIDS Conference in Vienna today. The study also compared the rate of side effects between those who received Viread and those who got a placebo, and found no significant difference.
The study supports efforts to test whether drugs approved to treat AIDS patients can also be used to prevent infections in the first place. That theory, called pre-exposure prophylaxis, or PrEP, was partially validated this week when a vaginal gel containing Viread was shown to reduce infections by 39 percent among women in South Africa. "It is encouraging to hear there were no serious safety concerns and that the men in the study did not appear to increase risk-taking behaviors while taking a pill," said Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition, in an e-mailed statement. "Much more safety, adherence and risk data will be needed before PrEP can be implemented if it is proven effective."
Researchers with the Oslo University and Bionor Immuno at the XVIII International AIDS Conference in Vienna, Austria, recently released the results of a re-vaccination study of Norway's largest hospital using the company's furthest advanced HIV vaccine candidate, Vac-4x. Researchers said 26 of the 40 HIV patients from a 2002-2003 phase IIa study were re-vaccinated between January and June 2010. The 22 patients were studied prior to a voluntary "re-boost" of Vacc-4x. Results from the reboost of the 26 patients are expected in August or September. "The Vacc-4x immunization technology using short peptide analogues to conserved viral protein domains has shown not only development of surprisingly long-term immunological memory T cells in these immunocompromised patients, but also that viral sequences changes during intermittent treatment interruptions were negligible," Professor Dag Kvale, co-author of the study, said.
At the recent International AIDS Conference in Vienna, Austria, Health Minister Dr Aaron Motsoaledi appealed to donors to desist from cutting aid to support AIDS programmes in sub-Saharan Africa. The irony of his call, however, is that countries in Africa are not increasing their spending on health. In 2001 at a meeting in Abuja, Nigeria, African countries committed to increase their expenditure on health to 15%. But to date, most African countries spend between 8% - 9% of their Gross Domestic Product (GDP) on health. Only a few countries such as Malawi have honoured the commitment. While they are delaying to improve their health spending, African governments are asking donor nations and agencies to sustain and increase their financing of AIDS programmes. As for South Africa, although it has the highest health budget than any other African country, it also falls far short of meeting the 15% target.
The new UN Entity for Gender Equality and the Empowerment of Women will pump the bulk of its projected US$500 million annual budget into programming to directly benefit the world's most vulnerable women, but this unprecedented boost may still leave the agency lacking influence and impact, civil society advocates say. The base funding for this entity, known as UN Women, more than doubles all the resources now available to the four UN gender agencies -- UN Development Fund for Women (UNIFEM), the Office of the Special Adviser on Gender Issues and Advancement of Women, the Division for the Advancement of Women, and the International Research and Training Institute for the Advancement of Women (INSTRAW). UN Women will formally come into being in January 2011. UNIFEM Deputy Executive Director Moez Doraid says $500 million is still "miniscule, compared to our needs, and those are enormous needs."
Gilead's HIV drug tenofovir is safe to be given to men at high risk of contracting the virus as a preventative measure, scientists said on Friday, but further trials are needed to test its efficacy. Researchers from the Centers for Disease Control and Prevention (CDC) in the United States studied the safety of the drug in gay and bisexual men who did not have the human immunodeficiency virus (HIV) that causes AIDS and said their results showed there were no concerns. "We didn't find any increased risk of harm in medical terms, and on the behavioural side the preliminary work we've done also suggests there is no increased risk," said Lisa Grohskopf, who led the study and presented the findings at the International AIDS Conference in Vienna. The approach of taking a daily antiretroviral drug to try to prevent HIV infection is known as pre-exposure prophylaxis, or PrEP. Scientists around the world are currently conducting studies to see if it may be an effective way to reduce HIV infection in high-risk groups, including gay men.
A successful microbicide trial and the promise of HIV treatment as prevention have dominated the scientific breakthroughs making headlines at the International AIDS Conference in Vienna, but scientists working on a cure for HIV say they are making slow but significant headway in finding a permanent solution to the epidemic. The main focus of current research is how to find and tackle "reservoirs" -- cells, organs or tissue in the body where the virus could remain latent -- and eventually become active again. "Cells harbour HIV for long periods of time, and there are so many different types of cells that move all over the body; these reservoirs can be located anywhere these cells can reach," said Maureen Goodenow, a professor of pathology at the University of Florida.
Current research is seeking a "functional cure", which would not eliminate the virus from the body but would allow a patient's immune system to control the virus without the need for lifelong medicine by using antiretroviral (ARV) drugs and medications for a limited period to target these reservoirs. At least two clinical trials are underway in France to test such products.
As the HIV/AIDS epidemic continues to spread, new research shows it's taking an increasing toll on men-having-sex-with-men or MSM. The issue was addressed at the 18th International AIDS conference in Vienna, with calls for greater funding and human rights efforts. Activists say men having sex with men have been hit hard by the epidemic, but have not received nearly as much attention or resources as many other groups. They're hoping scientific data on the effects of HIV on MSM -- released at the conference -- will change that.
From pre-conference events to the massive human rights march through downtown Vienna, world leaders, public health experts and HIV activists honed in with laser-like precision on a common message at The 18th International AIDS Conference in Vienna : The ongoing persecution and criminalization of gay, bisexual and other men who have sex with men -- "MSM", in public health shorthand -- are undermining efforts to control the global HIV/AIDS pandemic.
Chief among the obstacles: More than 80 nations have laws that still criminalize same sex behavior. In some of these countries, conviction can even result in the death penalty, reports UNAIDS. Further exacerbating the problem, according to a report by Planned Parenthood, "58 countries have laws that criminalize HIV or use existing laws to prosecute people for transmitting the virus. Another 33 countries are considering similar legislation.'
The trend is "even more pronounced" across Africa and the Diaspora, said Joel Gustave Nana, executive director of the Johannesburg, South Africa-based African Men for Sexual Health and Rights (ASMSHer). The West African laws vary in extremity -- just "exposing a person to HIV, regardless of if the virus is transmitted, is a crime in Benin, and Tanzanian law carries a possible sentence of life in prison for intentional transmission," reports Medical News Today. While the overall life for Black MSM may be better for in North America, there are drawbacks. The United States and Canada lead the world when it comes to prosecuting people who infect or expose others to HIV, a surprising new study reveals. Black men have been disproportionately targeted with these prosecutions. A Black, gay, HIV positive Michigan man was recently as charged as a bioterrorist for allegedly biting a neighbor's lip during a scuffle, Black AIDS Weekly reported in June.
Vaccine manufacturers in India and other developing countries may be able to produce a lower-cost HPV vaccine in spite of the complicated array of patent protections on the technology, say researchers at the Duke Institute for Genome Sciences & Policy. At a cost of at least $300 for the three-dose regimen, the blockbuster HPV vaccines, including Gardasil((R)) from Merck and Cervarix((R)) from GlaxoSmithKline, are some of the most expensive ever introduced.m"Three hundred dollars is a lot of money, and when you consider the disproportionate burden of HPV-induced cervical cancer on low-income countries, the potential for disparity becomes even more obvious," said Subhashini Chandrasekharan, a researcher within the IGSP's Center for Genome Ethics, Law & Policy. "We wanted to address one of the barriers to producing a cheaper vaccine."
Will a new version of the female condom catch on? Officials in HIV-ravaged Washington, D.C., certainly hope so. They've launched a citywide campaign to get women and their partners to think about giving the new and improved disease- and unwanted pregnancy buster a try. The original version was a bit of a dud. At about $3.60 apiece, it was expensive. Some said the material, polyurethane, reminded them of a doctor's examination glove and sounded like a crinkling plastic bag during sex. And some women didn't like the way it looked, as part of it hangs out of the vagina. The new condom, which was approved by the FDA last year, is made of d nitrile, which is reportedly less noisy. It's also less expensive - about $2 - though that's still more expensive than a male condom. Like the old version, it's a flexible pouch wider than a male condom but similar in length.
Charlene Cotton will talk to anyone about sex. Several days a week she stands behind a table decorated with a bowl of flavored condoms and safer sex pamphlets, calling to women passing on the street, "Come check out my table. Don't be scared." She asks: "Have you heard of the female condom?" Then, to show how it works, she picks up her demonstration kit -- a condom and anatomical models.
It's a seemingly awkward conversation to have on a city street, but Cotton isn't embarrassed. She's part of a citywide effort to promote female condoms in the hope they can help stop the spread of HIV in Washington, which has one of the highest infection rates in the country. Community groups are handing out 500,000 of the female condoms, flexible pouches that are wider than a male condom but similar in length, during instruction sessions at beauty salons, barber shops, churches and restaurants. CVS is selling them in all its District of Columbia drugstores -- though sales so far are slow -- making Washington the only place where people can get them outside a health clinic or community group. And city officials are starting another promotion: a website and posters on 460 buses, about a third of the city's fleet.
Antigenics says it has achieved positive results in an early stage human trial for a potential herpes vaccine. A vaccine, if approved, would be a blockbuster pharmaceutical product -- 60 million Americans are infected with herpes simplex virus-2, more commonly known as genital herpes. Officials at the Lexington-based company say the findings show that Antigenics' proprietary vaccine platform that is focused on so-called heat shock proteins, which are found in all cells and play a role in helping the immune system to recognize diseased cells. While the initial focus of development has been in HSV-2, Antigenics says the technology platform can potentially be utilized for treatment of many types of infectious diseases such as HIV, hepatitis, malaria and tuberculosis. The potential vaccine would treat, not prevent, herpes. However the treatment, if effective, would decrease transmission of the disease. The phase 1 study included 35 patients who had tested positive for herpes simplex virus - 2. The study showed that the majority of patients had two types of immune system responses to the vaccine.
The National Cancer Institute has awarded researchers $4.1 million to test whether the microbicide Carraguard® can prevent of new human papillomavirus (HPV) infections in women. Carraguard was tested against HIV, but was not effective. However, it is estimated to be 1000 times more effective against HPV. HPV causes virtually all cases of cervical cancer, a deadly disease. It is the most commonly sexually transmitted infection in young adults. Effective cancer screening in developed countries prevents many infections from progressing to cancer. But according to the World Health Organization, cervical cancer is the second-leading cause of female cancer deaths worldwide, accounting for more than 250,000 deaths each year. More than 85 percent of these cases occur in developing countries.
According to the World Health Organization, approximately 440 million males and females are infected with HPV worldwide. The Centers for Disease Control estimates at least 20 million Americans have HPV. Current HPV vaccines do not provide adequate protection for women already infected with HPV and are too expensive for most women in developing countries. Making matters worse, condoms are not always effective at preventing infection and problems are associated with approved vaccines. A safe, reliable and inexpensive microbicide, a substance that would prevent transmission of HPV, could protect women around the world from HPV infection and its potentially deadly consequences.
Mayo Clinic researchers are heading up a new cooperative research model for clinical trials that could take years out of the life cycle of a trial and accelerate the amount of time it takes to translate the results to new drugs and treatments. More than 3,100 institutions in the United States contribute to group-conducted clinical trials, but often those large-scale trials conducted in multi-institutional settings can produce unnecessary administrative and technical burdens. Mayo is hoping to pioneer a better way.
Rochester, Minn.-based Mayo biostatistician Daniel Sargent will lead a 90-member team at Mayo Clinic's three campuses, including the one in Jacksonville, and Duke University to implement a single, Web-based system for data collection and management of clinical trials and other changes to streamline the process. The initiative is a byproduct of the National Institute of Medicine, and its recognition that the National Cancer Institute's Clinical Trials Cooperative Group Program was in need of an overhaul. Although NCI for 50 years has played a key role in developing new and improved cancer therapies, the program was falling short of its potential to conduct the timely, large-scale clinical trials needed to improve patient care.
Dapivirine, a nonnucleoside reverse transcriptase inhibitor, is in development as a microbicide for the protection of women against HIV infection. A randomized, double-blind, phase 1 trial was conducted in 36 healthy HIV-negative women to compare the pharmacokinetics of 2 dapivirine vaginal gel formulations (0.05% each) and their safety with the hydroxyethyl cellulose-based universal placebo gel. Gel was self-administered once daily for a total of 11 days. Blood and vaginal fluid samples were collected sequentially over 24 days for pharmacokinetic analysis. Safety was evaluated by pelvic examination, colposcopy, adverse events, and clinical laboratory assessments. Adverse event profiles were similar for the 3 gels. Most events were mild and not related to study gel. Headache and vaginal hemorrhage (any vaginal bleeding) were most common. Plasma concentrations of dapivirine did not exceed 1.1 ng/mL. Steady-state conditions were reached within approximately 10 days. Dapivirine concentrations in vaginal fluids were slightly higher for Gel 4789, but Cmax values on days 1 and 14 were not significantly different. Terminal half-life was 72-73 hours in plasma and 15-17 hours in vaginal fluids. Both formulations of dapivirine gel were safe and well tolerated. Dapivirine was delivered to the lower genital tract at concentrations at least 5 logs greater than in vitro inhibitory concentrations.
An effective vaginal microbicide could reduce human immunodeficiency virus type 1 (HIV-1) transmission to women. Among microbicide candidates in clinical development is Maraviroc (MVC), a small-molecule drug that binds the CCR5 co-receptor and impedes HIV-1 entry into cells. Delivered systemically, MVC reduces viral load in HIV-1-infected individuals, but its ability to prevent transmission is untested. We have now evaluated MVC as a vaginal microbicide with use of a stringent model that involves challenge of rhesus macaques with a high-dose of a CCR5-using virus, SHIV-162P3. Gel-formulated, prescription-grade MVC provided dose-dependent protection, half-maximally at 0.5 mM (0.25 mg/mL). The duration of protection was transient; the longer the delay between MVC application and virus challenge, the less protection (half life of 4 h). As expected, MVC neither protected against challenge with a CXCR4-using virus, SHIV-KU1, nor exacerbated postinfection viremia. These findings validate MVC development as a vaginal microbicide for women and should guide clinical programs.
Changes in the rates of condom use and number of sexual partners were evaluated among 140 female sex workers in Kibera, Kenya, participating in a 6-month study of diaphragm safety and acceptability for prevention of sexually transmitted infections conducted in 2004-2005. Analyses were stratified by partner type. Multivariable Tobit regression modeling was used to assess the association between study visit and proportion of acts protected. Participants completed 140 baseline visits and 390 bimonthly follow-up visits. The mean percentage of coital acts reported as protected by a condom increased from 56% at baseline to 68% at the 6-month visit (P < 0.01). Similar increases were observed for condom use by all partner types. Additionally, the mean number of sexual partners decreased over the study. Furthermore, consistent (i.e., 100%) diaphragm use during follow-up was associated with a higher proportion of coital acts protected by a condom in analyses adjusted for study visit and coital frequency. These findings suggest that, despite concerns that introduction of the diaphragm would result in more risky sexual behaviors, reported condom use increased and number of partners decreased.
Background The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented.
Methodology/Principal Findings Data were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in "clinical trial culture" that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutions.
Conclusions/Significance The integration of qualitative social science and the use of mixed methods and triangulation in clinical trials are feasible, and can reveal (and resolve) inaccuracies in data on adherence and sensitive behaviours, as well as illuminating aspects of "trial culture" that may also affect data accuracy.
Background Accurate data on adherence and sexual behaviour are crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. The Microbicides Development Programme has developed a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour.
Methodology/Principal Findings Data were collected from a random subsample of 725 women using structured case record form (CRF) interviews, coital diaries (CD) and in-depth interviews (IDI). Returned used and unused gel applicators were counted and additional data collected through focus group discussions and ethnography. The model is described in detail in a companion paper . When CRF, CD and IDI are compared there is some inconsistency with regard to reporting of sexual behaviour, gel or condom use in more than half. Inaccuracies are least prevalent in the IDI and most prevalent in the CRF, where participants tend to under-report frequency of sex and gel and condom use. Women reported more sex, gel and condom use than their partners. IDI data on adherence match the applicator-return data more closely than the CRF. The main reasons for inaccuracies are participants forgetting, interviewer error, desirability bias, problems with the definition and delineation of key concepts (e.g. "sex act"). Most inaccuracies were unintentional and could be rectified during data collection.
Conclusions/Significance The CRF -- the main source of self-report data on behaviour and adherence in many studies -- was the least accurate with regard to measuring sexual behaviour, gel and condom use. This has important implications for the use of structured questionnaires for the collection of data on sexual behaviour and adherence. Integrating in-depth interviews and triangulation into clinical trials could increase the richness and accuracy of behavioural and adherence data.
Although transactional sex has been linked to undesirable sexual health outcomes, there is a lack of clarity as to the meaning of the practice, which appears to extend beyond behaviors related to women's economic circumstances. This article explored the perspectives of parents and unmarried young people on motivations for, and beliefs about, transactional sex in rural Tanzania using an ethnographic research design. Data collection involved 17 focus groups and 46 in-depth interviews with young people aged 14-24 years and parents/caregivers. Transactional sex was widely accepted by both parents and young people. Male parents equated sexual exchange to buying meat from a butcher and interpreted women's demand for exchange before sex with personal power. Young men referred to transactional sex as the easiest way to get a woman to satisfy their sexual desires while also proving their masculinity. Young women perceived themselves as lucky to be created women as they could exploit their sexuality for pleasure and material gain. They felt men were stupid for paying for "goods" (vagina) they could not take away. Mothers were in agreement with their daughters. Although young women saw exploitation of the female body in positive terms, they were also aware of the health risks but ascribed these to bad luck. Interventions aimed at tackling transactional sex in the interests of women's empowerment and as a strategy for HIV prevention need to understand the cultural beliefs associated with the practice that may make it thrive despite the known risks.
Background . Human immunodeficiency virus type 1 (HIV-1)-specific cellular immunity contributes to the control of HIV-1 replication. HIV-1-infected volunteers who were receiving antiretroviral therapy were given a replication-defective adenovirus type 5 HIV-1 gag vaccine in a randomized, blinded therapeutic vaccination study. Methods. HIV-1-infected vaccine or placebo recipients underwent analytical treatment interruption (ATI) for 16 weeks. The log(10) HIV-1 RNA load at the ATI set point and the time-averaged area under the curve served as coprimary end points. Immune responses were measured by intracellular cytokine staining and carboxyfluorescein succinimidyl ester dye dilution. Results. Vaccine benefit trends were seen for both primary end points, but they did not reach a prespecified significance level of [Formula: see text]. The estimated shifts in the time-averaged area under the curve and the ATI set point were 0.24 ([Formula: see text], unadjusted) and 0.26 ([Formula: see text], unadjusted) log(10) copies lower, respectively, in the vaccine arm than in the placebo arm. HIV-1 gag-specific CD4(+) cells producing interferon-gamma were an immunologic correlate of viral control. Conclusion. The vaccine was generally safe and well tolerated. Despite a trend favoring viral suppression among vaccine recipients, differences in HIV-1 RNA levels did not meet the prespecified level of significance. Induction of HIV-1 gag-specific CD4 cells correlated with control of viral replication in vivo. Future immunogenicity studies should require a substantially higher immunogenicity threshold before an ATI is contemplated.
Background A candidate vaccine consisting of human immunodeficiency virus type 1 (HIV-1) subunit gp120 protein was found previously to be nonprotective in an efficacy trial (Vax004) despite strong antibody responses against the vaccine antigens. Here we assessed the magnitude and breadth of neutralizing antibody responses in Vax004.
Methods Neutralizing antibodies were measured against highly sensitive (tier 1) and moderately sensitive (tier 2) strains of HIV-1 subtype B in 2 independent assays. Vaccine recipients were stratified by sex, race, and high versus low behavioral risk of HIV-1 acquisition.
Results Most vaccine recipients mounted potent neutralizing antibody responses against HIV-1MN and other tier 1 viruses. Occasional weak neutralizing activity was detected against tier 2 viruses. The response against tier 1 and tier 2 viruses was significantly stronger in women than in men. Race and behavioral risk of HIV-1 acquisition had no significant effect on the response. Prior vaccination had little effect on the neutralizing antibody response that arose after infection.
Conclusions Weak overall neutralizing antibody responses against tier 2 viruses is consistent with a lack of protection in this trial. The magnitude and breadth of neutralization reported here should be useful for identifying improved vaccines.
In June, PLoS Medicine published a series of articles on interventions to tackle the burden of maternal, neonatal, and child mortality in sub-Saharan Africa and how to implement those interventions most effectively. Reducing child mortality and improving maternal health are two of eight Millennium Development Goals (MDGs) agreed to by 191 UN member states. The lack of progress on these goals so far means that the 2015 targets for maternal and child health are unlikely to be met. ... Although tackling HIV is a priority within the MDGs, it is linked to other infectious diseases -- namely malaria and tuberculosis -- and is not specifically included in the MDGs for maternal and child health... The July issue of PLoS Medicine features two magazine articles that further highlight the importance of tackling HIV in the context of women's and child health...
Editor's Note: See also the following links to abstracts of additional articles published in the July issue of PLoS Medicine:
EUROPRISE is a Network of Excellence sponsored from 2007 to 2011 by the European Commission under the 6th Framework Program. The Network encompasses a wide portfolio of activities ranging from an integrated research program in the field of HIV vaccines and microbicides to training, dissemination and advocacy. The research program covers the whole pipeline of vaccine and microbicide development from discovery to early clinical trials. The Network is composed of 58 partners representing more than 65 institutions from 13 European countries; it also includes three major pharmaceutical companies (GlaxoSmithKline, Novartis and Sanofi-Pasteur) involved in HIV microbicide and vaccine research. The Network displays a dedicated and informative web page: www.europrise.org. Finally, a distinguishing trait of EUROPRISE is its PhD School of students from across Europe, a unique example in the world of science aimed at spreading excellence through training. EUROPRISE held its second annual conference in Budapest on November, 2009. The conference had 143 participants and their presentations covered aspects of vaccine and microbicide research, development and discovery. Since training is a major task of the Network, the students of the EUROPRISE PhD program summarized certain presentations and their view of the conference in this paper.
Background The performance of coital diaries (CDs) and clinic-based interviews to measure sexual behavior was compared during a pilot study for a Phase III microbicide trial.
Methods In Mwanza, 59 women were enrolled for 4 weeks and provided with 20 placebo gels. Weekly, women were given CDs to complete daily. At the final clinic visit, women attended a face-to-face interview (Clinic FFI) about their sexual behavior, and the gel use was accounted for (gel accountability (GA)). Comparisons were made between CD, Clinic FFI, and GA data. In-depth interviews following clinic visits elicited reasons for discrepancies in reports.
Results Twice as many sex acts during 1 week were recorded in the CD (median 4) compared with the clinic FFI (median 2). At the clinic FFI, more women reported using the gel for each sex act (84% vs. 40%; P < 0.001) and vaginal washing for each sex act (98% vs. 56%; P < 0.001) compared with the CD. Over 4 weeks, 16.4% of women recorded sex during menstruation in CDs compared with 1.8% at the clinic visit (P = 0.01). The median number of gels used reported in the CDs was the same as the GA (10) with 59% agreement on the number used within +/-2 gels. Reasons for misreporting during clinic FFI were reported to have been poor recall, embarrassment, or misunderstanding. Inaccuracies in CDs were attributed to misunderstanding or poor recording.
Conclusions CDs elicited higher recording of sex acts and lower reporting of gel use than clinic FFIs, which has implications for measuring adherence during clinical trials. With clear instructions and support, coital dairies should be considered in future microbicide trial design.
The aim of this study was to define the effects on antigen-presenting cells of the expression of HIV antigens from an attenuated poxvirus vector. We have analyzed the transcriptional changes in gene expression following infection of human immature monocyte-derived dendritic cells (DC) with recombinant modified vaccinia virus Ankara (MVA) expressing the genes encoding the gp120 and Gag-Pol-Nef antigens of HIV type 1 clade B (referred to as MVA-B) versus parental MVA infection. Using microarray technology and real-time reverse transcription-PCR, we demonstrated that the HIV proteins induced the expression of cytokines, cytokine receptors, chemokines, chemokine receptors, and molecules involved in antigen uptake and processing, including major histocompatibility complex (MHC) genes. Levels of mRNAs for interleukin-1, beta interferon, CCR8, and SCYA20 were higher after HIV antigen production. MVA-B infection also modulated the expression of antigen processing and presentation genes: the gene for MICA was upregulated, whereas those for HLA-DRA and HSPA5 were downregulated. Indeed, the increased expression of the gene for MICA, a glycoprotein related to major histocompatibility complex class I molecules, was shown to enhance the interaction between MVA-B-infected target cells and cytotoxic lymphocytes. The expression profiles of the genes for protein kinases such as JAK1 and IRAK2 were activated after HIV antigen expression. Several genes included in the JAK-STAT and mitogen-activated protein kinase signaling pathways were regulated after HIV antigen expression. Our findings provide the first gene signatures in DC of a candidate MVA-B vaccine expressing four HIV antigens and identified the biological roles of some of the regulatory genes, like that for MICA, which will help in the design of more effective MVA-derived vaccines.
GMHC and the HIV Center for Clinical and Behavioral Studies present AIDS 2010: The New York City Perspective on the XVIII International AIDS Conference
Date/Time: Thursday, August 5, 2010 9:30 AM to 11:30 AM Location: The Tisch Building, 11th floor, 119 West 24th Street, NYC (between 6th and 7th Avenues)
Featuring presentations and reports from local participants at the recent International AIDS Conference in Vienna, Austria. This event is free and open to the general public. Light refreshments will be served. For more information, please call (212) 367-1016 or write to firstname.lastname@example.org.
The Population Council's 2009 Annual Report is now available online. In this year's report, Population Council staff members take you to the grassroots of our work so that you can understand the impact of our research and programs on HIV and AIDS; poverty, gender, and youth; and reproductive health. Also available are multimedia resources about the many projects presented in the 2009 Annual Report.
Request for Applications (RFA) Number: RFA-AI-10-027
Key Dates Opening Date: September 9, 2010 (Earliest date an application may be submitted to Grants.gov)
Purpose This FOA issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), solicits Research Education Grant (R25) applications from institutions/organizations that propose to create a supportive environment nationwide in the United States for participation in biomedical HIV prevention trials. The program will support innovative, evidence-based approaches to educate and engage U.S. populations most highly affected by HIV and AIDS (see http://www.cdc.gov/hiv/topics/surveillance/index.htm for more information) about clinical biomedical prevention research. This FOA will provide support for the formation of partnerships on a national scale among scientists, educators, media experts, community leaders, and other members of stakeholder organizations to enhance knowledge and understanding within highly HIV-affected communities of clinical biomedical HIV prevention research. Clinical biomedical HIV prevention research includes but is not limited to HIV vaccine research, microbicide research, pre-exposure prophylaxis research, and research on "test and treat" strategies for reducing HIV incidence.
Mechanism of Support This FOA will use the NIH Research Education (R25) grant mechanism. Research education programs may not be transferred from one institution to another, unless strongly justified (see Section VI.2).
Funds Available and Anticipated Number of Awards The NIAID intends to commit up to $1.8M in total funding in FY2011 to fund one award in response to this FOA. An award issued under this FOA is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Budget and Project Period Budgets for direct costs up to $1.8M per year and project duration of up to five years may be requested for a maximum of $9.0M direct costs, over a five-year project period.
Formally released at the 2010 AIDS Conference, this handbook provides practical guidance to clinical trial staff and research partners on how to anticipate and respond to the special communications challenges posed by the conduct of clinical research. Using context-specific case studies and practical insights culled from actual communications experience in clinical trials from around the world, this essential new resource covers the spectrum of communications planning, activities, and strategies involved in the implementation of a clinical trial. Organized to correspond to the chronological steps involved in conducting research, this guide focuses on the various communications skills that are needed throughout the course of a trial.
Designed to be accessible and relevant to a wide audience, Communications Handbook for Clinical Trials will make your job easier, whether you are a researcher, a study coordinator, or a communications professional. The handbook contains diagnostic tools, sample templates, and materials that research sites can adapt for use in their communications planning and implementation. Communications Handbook for Clinical Trials includes:
Sample communication plans for clinical trials
Communications and crisis-planning templates and checklists
Scenario-planning tools to facilitate planning for the release of trial results
Ideas on delegating communications tasks to reduce demands on key site personnel
Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media
November 17-19 2010 Gaylord National Hotel, National Harbor, MD CALL FOR ABSTRACTS
The Scientific Planning Committee for the 2010 National Summit on HIV Diagnosis, Prevention and Access to Care is issuing a Call for Abstracts for presentations at the upcoming National Summit conference.
Online Abstract submission begins: August 06, 2010