How did you get involved in Microbicide research?

My wife (Quarraisha) and I are both involved in microbicide research. Our background knowledge and introduction to microbicides was through Zena Stein who published a seminal paper entitled ‘€œHIV Prevention: The Need for Methods Women Can Use” in the American Journal of Public Health.

She is the ‘€œmother’€ of microbicides. Her passion was to launch a project of a microbicide that would be woman controlled and effective.  She mentored my wife and I. It was her interest that got us involved in microbicides research.

How long have you been in microbicide research?

We have both been involved in microbicide research for over 14 years. In 1989 we decided to focus our research on HIV prevention. In 1996, we started a study to test the effectiveness of Nonoxynol ‘€“ 9. We got a call from a health inspector in Ladysmith, who wanted help with prevention messaging for sex workers in the area.

We drove there one day to see if we could help and met with the sex workers. When we got there we saw several trucks and one-by-one the sex workers arrived for their meeting with us. It was a remote area but there so many of them. It was in a small town. We didn’€™t know where they were coming from. We met with the sex workers and gave a talk about HIV prevention. They were interested in the information.   We approached them with an idea for our study to help prevent HIV infection and asked them if they were interested in participating in it.  

They wanted to participate if one of them could be allowed to liaise on their behalf. One of the women was trained on prevention and worked with us. We did the study and from then we got involved in many other trials including Pro2000 more recently Caprisa 004.

Can you tell me more about Caprisa 004?

It is a double-blind, placebo-controlled randomised trial to test the safety and effectiveness of tenofovir gel in preventing HIV infection. I approached Gilead in 2004 and asked to use tenofovir as a gel in an HIV prevention study. They told me that they were not pursuing tenofovir development in gel form. They said it might be a good idea to pursue it as an oral prevention tablet. But I felt that gel would be an important option for women to use for HIV prevention due to the difficulties we have had in getting women to take contraceptive pills regularly.

They gave us 22 kg of raw tenofovir and were willing to consider providing a non-exclusive license for the product so that should it become effective it would be cheaper to roll out as a not-for-profit agent in Africa. We started the study in 2007. Critics said it was a doomed study and we were going to fail. But the need was too great and how could I stand idly by while a promising HIV prevention strategy may be available?

We started the study on time and finished it on time. We gave it the best we could and followed all the guidelines for good clinical practice in conducting research.

How much did the trial cost?

The total cost has not yet been calculated. We needed about R 100 million to run the trial. The South African government’€™s Department of Science & Technology contributed R8 million. We still needed 92 million. The United States Agency for International Development (USAID) of the United States government committed the remainder.

If this product works what’€™s the next step?

The most important thing would be to do a confirmatory study. That needs to be done as soon as possible. We sometimes tend to wait too long to confirm the results. Doing the study sooner rather than later would make it more likely that we could have the product available by 2013-2015, if it is found to be effective.

We have already started discussions about who would do a confirmatory study in South Africa and internationally.  

 Data from the VOICE Study ‘€“ Vagina and Oral Interventions to Control the Epidemic ‘€“ will also be important as well as data currently released on the safety of the product during pregnancy.

What if the product is not successful?

If it does not show HIV protection we need to find out why. There are questions that would need to be answered such as:

– Should the trial participants use larger amounts of gel?

– Should the time of application be extended?

– Did the women in the trial use the product?

In such trials we rely mostly on self reporting as a way of measuring adherence and sometimes that is not accurate enough. Another way we used was to collect every applicator issued every month.

There is a quite a number of trials taking place testing the effectiveness of the compound tenofovir as a prevention method. Are we not putting all our eggs in one basket?

I don’€™t think so. Yes, most studies are testing tenofovir and that is because it is the only antiretroviral that is that we have that has been effective as a treatment with few side effects. There are other drugs that are coming into the market that will be included in coming trials such as dapivirine and UC781

What is the future of prevention?

Combination prevention – that is when all prevention methods will be used together. That is when, for example, circumcision will be used alongside a condom and education. Added to that at some time in the future, I hope would be an effective vaccine or microbicide.