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Archive for the ‘microbicides’ Category

3pm – Just announced: The U.S. National Institutes of Health (NIH) is now the first patent-holder to share intellectual property with the Medicines Patent Pool. The pool is a recently-established initiative – funded by UNITAID – to expand access to treatments in developing countries. The announcement is here.

Ken Mayer – co-chair of the Center’s Scientific Advisory Committee – has a review article on the use of antiretroviral therapy (ART) as HIV prevention in this month’s issue of the American Journal of Public Health. In it, he and co-author Kartik Venkatesh, PhD, discuss the status and prospects for successful use of ART in decreasing HIV transmission globally.

Plan USA released the video above as part of its “Because I Am a Girl” campaign, which focuses this year on how the digital world impacts women and girls. Kate Darlington gives a good overview of the report and campaign at Change.org, relating it to the increasing focus on women and girls as the key to reducing poverty and disease. The report, called “Digital and Urban Frontiers: Girls in a Changing Landscape,” is available through Plan USA [PDF].

HIV infection in Ukraine continues to spread, with the government doing little to intervene. David L. Stern at GlobalPost writes that the ex-Soviet republic has an estimated 360,000 people living with AIDS or HIV.

CAPRISA researchers – who released news of a groundbreaking vaginal gel that would give women the power to protect themselves from HIV this summer – are struggling to find funding (more…)

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The U.S. government is working to bridge the gap in funding needed to continue the encouraging CAPRISA vaginal microbicide research trial with a combination of funding from USG, the South African government and possibly private donors.

Sources say this is in response to a New York Times piece that ran on September 3 entitled “HIV Prevention Gel Hits Snag: Money.” In the article, author Celia Dugger reports that donors have only committed approximately $58 million of the $100 million needed to carry one of the two confirmatory studies from launch to completion.  

Researchers reported the CAPRISA 004 trial results at the 18th International AIDS Conference in Vienna in July. The South African study showed that of the nearly 900 women enrolled in the study, women who received one percent tenofovir gel had 39 percent fewer HIV infections compared to women who received the placebo gel.

Speeding the gel to widespread use is contingent upon the conclusions of this follow-up research. ScienceSpeaks has heard that donors are quickly rising to the occasion to fill the more than $40 million deficit.

According to Jeff Spieler, Senior Technical Advisor for Science and Technology at the United States Agency for International Development (USAID), they are hopeful that a major portion of that money is almost good to go. If Congress earmarks enough money for USAID in microbicide research and development in fiscal year 2011, USAID will commit $18 million over three years toward the confirmatory trial. The South African Department of Science and Technology will then put in $13.5 million, leaving the gap in funding of approximately $8.5 million.

“Hopefully other donors will fund that gap,” Spieler said.

Other encouraging news is that the U.S. Food and Drug Administration is likely to consider the microbicide gel arm of the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial as a CAPRISA confirmatory trial, according to Spieler.

One arm of the VOICE trial is looking at once-daily vaginal gel dosing of the same microbicide used in the CAPRISA trial. But unlike CAPRISA, the administration of the gel is not coitally dependent.

“If the women use the product correctly, then there is no reason to think women wouldn’t get the same or better results as those achieved in CAPRISA 004,” Spieler said.

The rub is in whether or not the trial participants consistently use the gel every day, regardless if they have sex or not.

The VOICE trial results should come out in the end of 2012 or early 2013.

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Director of  The Center for Global Health Policy Christine Lubinski is blogging today from Johannesburg, South Africa. This is her second entry from her visit to South Africa and Zambia, where she and other Center staff are hosting five congressional staff members on tours of U.S. government funded programs to address HIV and TB. 

Dr. Helen Rees describes the University of the Witwatersrand, Johannesburg (Wits), Institute for Sexual and Reproductive Health, with its myriad activities and programs, as both an academic institute and an agent for social change. 

While we and our congressional colleagues were visiting the Institute, a four-week residential course on research methods was underway. Five thousand health care workers each year are trained here on issues related to HIV, TB and reproductive health.  The Institute also does work on gender-based violence and is beginning to address the so-called lifestyle diseases—diabetes and hypertension—that also contribute substantially to morbidity and mortality in South Africa.  The program of the Institute includes health services provision, policy development, and advocacy and pioneering research.  The Institute was the first group to integrate prevention of mother to child transmission (PMTCT) programs with the provision of HIV treatment to women. They are currently engaged in 60 different active research programs funded by a range of donors including the U.S. through the National Institutes of Health and the President’s Emergency Plan for AIDS Relief, or PEPFAR.

Dr. Rees and her colleagues are also busy working with the government and other key civil society players on the development of a prevention research agenda for South Africa for the next five years.  (more…)

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Many themes emerged during the 18th International AIDS Conference last week in Vienna. Here is our list of the top five:

Universal Access to HIV Treatment and Prevention Remains Elusive Goal

From comments by Bill Gates to the many activist demonstrations, a main theme at IAS 2010 was fear over dwindling funds dedicated to the HIV/AIDS pandemic. The Obama administration took significant heat for recent budget proposals for FY2011 that indicate a retreat from the promise to fund global AIDS at $50 billion over the next five years. Austria also faced targeted criticism for not committing funds to the Global Fund, despite its role as the host country for IAS 2010.  Various speakers and activist actions also called out Canada, Germany and France for back-peddling on their commitment to global AIDS and the Global Fund, while African activists challenged their own leaders to honor the Abuja Declaration and to commit 15 percent of their respective budgets to health.

Also of note was the grave concern expressed by activists from Eastern Europe and citizens of the former Soviet Republics about changes in Global Fund eligibility criteria that may put their proposals at a disadvantage.  Numerous stories and presentations highlighted the failure of many of these governments to put resources into harm reduction and into treatment programs serving the highly stigmatized populations of injection drug users (IDU), commercial sex workers and prisoners who represent the major HIV-affected populations in the region.

Keeping Step with PrEP

There are many trials testing the ability of antiretrovirals (ARV) to prevent acquisition of HIV infection underway, and the results of two such trials gained quite a bit of attention at IAS 2010. (more…)

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During a press conference Tuesday at the International AIDS Conference in Vienna, Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases at NIH, describes the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial. The study is testing the safety and efficacy of microbicide gel containing the ARV drug tenofovir, and oral tablets containing tenofovir or a combination of tenofovir and emtricitabine known by the brand name Truvada.

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Bill Gates participated in a press conference Tuesday at the International AIDS Conference in Vienna. Here he addresses what roll-out of new treatment as prevention therapies might look like and how long roll-out of an approved treatment as prevention therapy would take.

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Here at the Microbicides 2010 conference in Pittsburgh I got a chance to talk with Dr. Gita Ramjee, one of the top researchers in the field, about the most exciting scientific challenges being discussed at the meeting.  Dr Ramjee is the Director of the HIV Prevention Research Unit at the South African Medical Research Council.  She also explains in the interview why development of an effective microbicide for rectal use is so crucial, for both men and women in Africa, in particular given higher than expected rates of reported anal sex in several countries, as well as in many other regions of the world including the United States.

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