http://timesofindia.indiatimes.com/articleshow/msid-2843441,prtpage-1.cms

Preventive technologies remain the only way to slow down AIDS which claims five million new infections every year. Microbicides will put prevention in the hands of women, more vulnerable both biologically and socially. Zeda Rosenberg, founder-president of the International Partnership for Microbicides (IPM), spoke to Bachi Karkaria of the hope that can be wrested from the persistent failures of clinical trials:

What is the basis for your optimism when all we have are controversies and failures?

We are trying to find the first vaginal microbicide, and against the most devious virus. There are bound to be many failures. But these have helped us arrive at the next generation of products. The early chemicals did not have higher longevity in the body. Today's new stronger, longer-lasting anti-retrovitrals (ARVs) used for treatment do. We had to get pharma companies to give us access to these drugs so that we could develop and license them for use as preventives.

What will ensure greater adherence, the sticking point in earlier trials?

We can have a more acceptable product delivery system since these new ARVs can stay potent in the body much longer - once-a-day gels or even once-a-month rings. These are coitally independent. Women found the earlier products inconvenient, or impossible, because they had to be used around the time of intercourse. The IPM's contribution has been to expand the number of drugs that can be developed into microbicide products, and to make the intravaginal ring into a feasible drug delivery system.

Will trials of GenNext microbicides also be designed differently?

Yes. Women will be contacted every day, not once a month or every three months. The empty gel applicator will be collected. The new smart applicators can tell us the time the gel was expelled as well as the body temperature at the time, a more reliable indicator of actual use. We always hope to maximise our ability to show that microbicides work against HIV, proof of concept. Then we can look at many more products and formulations, and pick the best products, and try them in the best-designed trials to give the product the greatest chance of working. We have to understand the exact degree of both safety and efficacy. After that, the community, that is women, will assess the risks and make a cost-benefit decision.

What are the lessons learnt?
That complicated trials involving very large numbers of women can be conducted, and that both science and ethics can be served. Indeed trials create the ideal HIV prevention because all participants get access to the highest standards of STD prevention, counselling, and free condoms. Then we see the difference between the groups using the active product and the one getting the placebo. Those found HIV+ at the start are referred to appropriate care. Those infected during the trial (not from the product), get good medical care.