Dr Jocelyn Moyes: Internationally there’s about 600 compounds that are in testing ‘ right through; but we’ve got six compounds that are in a phase III trial. Well most of the trials are happening in sub ‘ Saharan Africa and in fact the majority or almost all are happening in South Africa.
Yolisa: Microbicides research Director Dr Jocelyn Moyes. She’s based at Chris Baragwanath Hospital in Soweto ‘ one of the South African trial sites. This site is managed by the Reproductive Health Research Unit [RHRU].
Phase III is a critical stage in researching the microbicide. This is the stage where the efficacy or effectiveness of the product, which can be administered via a gel, cream, suppository or vaginal ring, is determined.
Dr Jocelyn Moyes: Those compounds [the six] are in phase 111 trial which is really where you need to get to because that’s the question you finally need to answer.
Yolisa: Not as straight forward as the health experts and researchers would like it though.
Dr Jocelyn Moyes: If we show that it’s effective; we’ve got all the other hurdles like registration. It has to be registered within a country. Nothing is as fast as we’d like, but it’s happening.
Yolisa: There are more hurdles that researchers have to deal with while searching for an effective microbicide. Reproductive Health Research Unit Head Professor Helen Rees.
Professor Helen Rees: ‘¦in terms of research investment versus the return of their investment [pharmaceutical companies] ‘ which is something they have to look at in terms of bottom line and their shareholders ‘ it doesn’t necessarily standout as a good research investment. For the world however – from a public health perspective and from a human rights and gender perspective; this is one of the most important investments we can make. Because of this ‘ the big pharmaceutical industries have not to date invested in any significant manner in the development of microbicides.
Yolisa: There’ve also been some concerns regarding the women who volunteer for trials. Delivering the key note address at last month’s Microbicide Conference in Cape Town ‘ health minister Manto Tshabalala said; while participants in clinical trials generally had to provide informed consent, researchers should refrain from infringing on their human rights. Professor Reese says they ensure that participants have a full understanding for their rights.
Professor Helen Reese: We always make it very very clear that what we’re doing is trying to find out if these products work. It’s important that before they consent to be in a trial ‘ that they understand that we don’t know if the microbicides we’re testing will work; we hope they will but we don’t know yet’¦.it’s very important that women participating in trials understand that this is research, we’re not trying out a proven product.
Yolisa: And the women volunteers appear to understand this Here’s one of the volunteers’¦
Trialist: My understanding is that they said they’re introducing a gel that could prevent HIV. That’s why I was interested because many people are dying of HIV. I have family friends and many people who’re dying of HIV.
Yolisa: She asked for her name not to be revealed. She’s one of the thousands of women in South Africa and around the world who have volunteered to participate in the clinical trials to test the efficacy of a range of microbicides. If successful; millions of new infections in the developing world could be prevented.
Researchers are hoping to have a microbicide which is applied as a gel that releases an anti ‘HIV ingredient – on the market in the next few years. In return, it could change women’s lives.
Dr Jocelyn Moyes: It will certainly give women a sense of control. And the control issue might be the fact that she could use it secretively. But also even if she negotiates it with her partner, she then still controls it. Much like contraception ‘ you know her partner might agree to it but she doesn’t want to rely on him to do it.
Yolisa: But men are not excluded. In fact; a conscious effort is made to ensure that they are part of the process. Here’s RHRU’s Mdu Mntambo who co-ordinates the social aspect of the microbicides research.
Mdu Mntambo: We also deal with men even though it is a vaginal microbicide because we want to understand the context that microbicide will be used. We want to know how men feel about the microbicides. Whether they like them and what do they like about them and if they don’t, we want to know what is it that they do not like.
Yolisa: And what are the usual concerns from men?
Mdu Mntambo: Because it is used during sex, some people want to know ‘ is it not going to affect their enjoyment of sex; is it not going to affect ability to reproduce you know.
Yolisa: And the answer?
Mdu Mntambo: Because we are running a trial, we discourage women from falling pregnant because we are testing a new drug. Prevention or contraception is always promoted. The gel is not designed to be contraceptive.
Yolisa: Some think the microbicides could be the biggest news since the pill. Health experts and researchers say ‘ when developed, an effective microbicide could be another weapon against HIV ‘ along other measures such as such as condoms and antiretrovirals.
Dr Moyes believes this project is exciting as it brings fresh hope.
Dr Jocelyn Moyes: It’s very easy to become terribly depressed about the HIV epidemic in this country and feel like we’re going nowhere. But I think this gives us something that could really change the pattern of the HIV epidemic; although at this stage it’s not looking like the microbicide will be as effective as a condom, it’s a good start and there’s lots of new stuff coming into the pipeline, so it’s incredibly exciting.