AIDS Action Committee’s Blog

Advocates for a new HIV prevention that would provide men and women with an alternative to condoms are reveling in our moment. The results of the first ever completed – not closed – microbicide trial of the product Carraguard are absorbing the trial’s results released today. The short answer is this study showed Carraguard, a microbicide derived from carrageenan which is more popularly known for it’s use in thickening food products, was safe to use and not harmful to women, but not effective in preventing HIV.

This is far from the end for microbicides, or HIV prevention research in general. We’re just making history. Carraguard was the first new microbicide candidate to enter clinical trials (in 1996) and the first to complete a Phase 3 trial. Other Phase 3 trials were stopped early for various reasons. These large-scale trials rely on participants to use the product consistently over a long period of time. Over 6,000 women participated in the Carraguard trial for up to two years, proving that such trials can be done with scientific rigor and ethical integrity.

More will be learned from this trial beyond Carraguard’s (lack of) efficacy as a gel that would allow women say in protecting themselves against HIV. What happened in these three South African sites where over 6,000 women volunteered their bodies and their sex lives for the greater good was a glimpse into their bedroom behaviors and the role research plays in the health of a community. Findings that may be considered ancillary to the research’s aim are perhaps the groundbreakers for advocates working with communities at risk, including those in South Africa: condom use by trial participants DOUBLED during the trial and STI rates decreased.

Add this to the reality that the presence of research infrastructure in these communities means increased access to health services for the trial volunteers, their partners and those who get screened but are not involved in the trial (over 9,000 people were screened in connection to this trial).

Opponents of research based on ethical concerns should have no issue with the Carraguard trial. The efforts by the researchers, by the advocates who relentless push for truly informed consent and access to care (think “No Woman Left Behind”) related to these trials, and by the women from the communities where the trial happened who fight stigma, sexual violence, and a lack of power in their primary relationships, all demonstrate how research can be the catalyst for a bigger intervention just awaiting the resources needed to make it happen.

Microbicide advocates have not run out of things to do. Three more candidate products are now in late clinical trials that will produce results soon. Developing new tools to prevent HIV– particularly among women – is an urgent priority. According to UNAIDS, approximately 3,500 women are becoming infected with HIV each day. Microbicide advocates have been actively, visibly and vocally involved in the process of microbicide research and development from the very beginning. Our involvement will continue until the goal in achieved – and safe, effective, accessible and affordable microbicides are in the hands of all who need them.

Word has quickly spread that (another) Phase III microbicide candidate has been taken off the shelf. Cellulose sulfate, an attachment inhibitor, may have been causing increased risk for HIV transmission in trials being done at several sites. As a result, these trials have been halted.
This news follows the closure of another phase III trial in August 2006. As Keith Alcorn wrote yesterday, that trial was showing “a lower than expected rate of HIV infections”. Though this is a less controversial reason for trial closure, both were cellulose sulfate and showed promise as contraceptive gels.
This is quite disheartening news for those of us working diligently to make microbicides a reality for the millions of women and men at risk for HIV through unprotected sex. Microbicides, a topical gel that could be used inside the vagina or anus during intercourse to reduce the likelihood of HIV transmission and possibly other STDs, would provide a non-barrier risk prevention option to the rather slim arsenal of HIV prevention options that currently exists.

Advocacy will now focus on the three products (all are not cellulose sulfate based) still in Phase III development, one of which is nearing completion and expected to have results by the end of this year. In the meantime, the microbicide advocacy community will continue to call for the necessary funding and support to meet the highest standards in HIV clinical trials and to put forth a greater inventory of promising candidate products.