By Anna Koblanck
Thursday, February 9, 2006
A new generation of vaginal gels promises women more power over their sexual health and protection against HIV. As South African women now test one product, investigators and analysts defend efforts to ensure their informed consent.
JOHANNESBURG, South Africa (WOMENSENEWS)--On a dusty backstreet just off the highway north of South Africa's capital Pretoria lies a simple, low building in the shade of a few trees. The research that takes place within that nondescript clinic could revolutionize women's sex lives and empower women across the globe in the battle against HIV and AIDS.
The Setshaba Research Centre is one of three sites in South Africa where a microbicide gel named Carraguard is being tested in phase 3 clinical trials, the last phase of drug testing on humans before approval for marketing.
More than 5,000 women are trying out the vaginal gel to determine if it really protects against HIV; most of them are from poor, neighboring areas.
"Studies done in the laboratory show that this agent might help in preventing HIV transmission," Dr. Khatija Ahmed, principal investigator at the research center, told Women's eNews. "It lines the vaginal mucosa so that the HIV virus cannot penetrate the mucosa and get into the human cell."
Investigators plan to test it on a total of 6,639 women in the country; some will be given Carraguard, some will be given a comparative gel that already has been proven in the laboratory not to protect against the virus.
Neither the study staffs nor the participants know who receives the microbicide gel and who the placebo. The program is being monitored by independent specialists with the charge of halting the project if safety concerns arise.
At the end of the study, scheduled for early 2007, researchers will compare the HIV rate of the two groups to see if there is any significant difference in HIV incidence. If women in the Carraguard group have 33 percent fewer infections than those in the placebo group, it will demonstrate that Carraguard provides partial protection against sexual transmission of HIV, said Dr. Sumen Govender, clinical study manager for the Population Council in South Africa.
In Africa HIV and AIDS spread mainly through heterosexual sex and women are at particular risk of contracting the virus. Already, a majority of those infected on the continent--13.5 million of 25.8 million--are women. This is partly because women are biologically more vulnerable to HIV infection and partly because many women have little power over their sex lives. Women are twice as likely as men to contract HIV from a single act of unprotected sex, but often find it very difficult to insist on using a condom if the male does not agree.
"My partner says that he does not like using a condom because it gives him some problems. He says it is very painful for him," said 31-year-old Victoria, one of the participants in the clinical trials at Setshaba Research Centre, who did not want to give her surname.
But while the product is stirring high hopes for combating AIDS, it is also stirring an ethical discussion.
Carraguard, developed by in-house researchers of the New York-based Population Council, is one of four microbicide projects in the world that have reached advanced clinical trials. One of the other microbicides was developed by the Global Microbicide Project, funded by the Seattle-based Bill and Melinda Gates Foundation. The other two were developed by two different biotech companies.
Carraguard and the three other microbicides will all be tested in Africa and India.
Carraguard is based on carrageenan, which is derived from seaweed. It is already being used in cosmetics and some food products, and is generally regarded to be safe for human use.
The Carraguard trials in South Africa--taking place in Pretoria, Durban and Cape Town--aim to establish whether the gel actually protects against HIV infection and also if it is safe for long-term use.
When asked about the general problem of women in the less developed world being used to test the microbicide, Dr. Ahmed, the Setshaba program's principal investigator, said it was necessary to conduct the trials in an environment of high HIV prevalence.
"The major pandemic is in Africa," said Dr. Ahmed. "If we sit back and wait for American or European countries to go through the trials and develop the product, it is going to take years for the product to actually reach the market because the HIV prevalence is not as high as here."
Anna Forbes is a program coordinator with the Global Campaign for Microbicides in Washington, D.C., which issued a 61-page report on the ethics of microbicide testing in March 2005. She said the AIDS epidemic is so massive that concerns about using inexperienced trial participants are outweighed by the benefits of bringing an effective microbicide to market as long as the trial is conducted ethically.
Eight thousand women each day develop indications of HIV infection, Forbes said. "That's immoral. Any dent you can make is worth it."
Forbes praised the Population Council's efforts to ensure subjects' informed consent by working closely with women in the program. "It's as fully informed as they can figure out how to make it," Forbes said. "Trying to convey what the trial is about is difficult."
Forbes noted that a side benefit of participating in the trials is that the women often have higher rates of condom usage than the general population.
The program is not without its critics. A recent article in the South African newspaper the Sunday Times reported that teen girls at schools in the area near the Setshaba Research clinic were skipping classes to take part in the trials. It also said some of the students, as young as 16, might have been encouraged to participate by the compensation fee of about $23 paid to each participant per visit to cover transportation costs, as required by the South African Medicines and Medical Devices Regulatory Authority. School staffs also expressed concern that the trials would be an incentive for the girls to start having sex.
In December, Dr. Rajen Misra, director of the clinical trials committee at the regulatory authority, said the South African Department of Health is very concerned about the risk of Africans being used as guinea pigs in medical research. Therefore, only testing of products that could be of great help to South Africans is allowed. He said the compensation fee stipulated by the government might look high for someone who is very poor, but is calculated to be enough for a person of middle income.
Mabitso Marumo, a senior counselor at the Setshaba Research Centre, said very few women cite the money as a reason for partaking in the trials, but it does happen.
"Some people will say that they came here for the money in the beginning, but after a while they think that the health benefits are the greatest, for example, the free tests and treatments for sexually transmitted diseases," she said.
Marumo expressed more concern about women who seem to forget that they are taking part in product testing and begin assuming the gel will really protect them against HIV infection. She might be right to be worried.
"Sometimes I use a condom and sometimes I use the gel. It is nice with just the gel," trials participant Victoria said.
Anna Koblanck is the Africa correspondent for the Swedish daily newspaper Dagens Nyheter and a freelance writer. She is based in Johannesburg, South Africa.
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