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.