Clinical Trial Launched With Hopes of Discovering New Prevention MethodGABORONE - With an estimated 270,000 people currently living with HIV/AIDS, Botswana is in desperate need of new and effective ways to prevent the spread of HIV. Researchers at BOTUSA are hoping to answer that call.
On May 4th, BOTUSA launched a new landmark study to determine whether taking a daily antiretroviral pill can actually prevent HIV infection among adults at risk. The concept, called pre-exposure prophylaxis, would be similar to taking an anti-malarial pill before traveling to a malaria-infected area. The TDF2 trial was launched during a breakfast ceremony in Gaborone, opened by the Botswana Minister of Health, with a goal of recruiting 1,200 young Botswana adults between ages 18-29 who are not infected with HIV.
In the first two months following the launch and new recruitment advertisements, the BOTUSA team screened more than 500 people as potential participants. "The response is tremendous but we still need more volunteers. We received many calls from people who wanted to know more about the study," says Dr. Poloko Kebaabetswe, a co-principal investigator of the study.
Minister of Health, the Hon. Professor Sheila Tlou, assured those at the launch that the Government of Botswana was a primary partner in the trial who would be looking after the interests of all participants. "Our Ministry of Health has reviewed and approved the trial and will monitor the wellbeing of the volunteers who have agreed to participate in the clinical study," she said.
"We remain hopeful, as a country reeling from the devastating effects of HIV and AIDS, that if this new prevention method is shown to be effective and safe, we may be able to slow down the epidemic significantly while we and the rest of the world wait for an effective vaccine or cure to be developed," Tlou said.
Carefully conducted clinical trials, like the TDF trial in Botswana, are the fastest and safest way to find treatments that work in human beings and ways to improve health, said U.S. Ambassador Katherine Canavan. "Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research," she said.
The director of the Division of HIV/AIDS Prevention at the U.S. Centers for Disease Control and Prevention (CDC), Dr. Robert Janssen, said the need for better prevention options was the biggest motivator for the trial.
"Abstinence works. Being faithful works as well. Condoms work. But we also know that most people are not abstinent, many people are not faithful, and many people do not use condoms the only way they really work, which is correctly and consistently. Or how else would 40 million people become infected with HIV worldwide?" Janssen said.
The trial involves the use of Truvada, a combination of the ARV medicines tenofovir and emtricitabine, which has proven effective in preventing the spread of a virus in animals. It is already widely used for treatment in the United States, Europe, and in some African countries. For treatment of HIV infection, it is taken once a day, doesn't cause many side effects, and is very slow to develop resistance. It has been tested in a few people without HIV infection for a short period of time and has appeared safe.
Dr. Kebaabetswe said that in order to keep the trial objective, half of the participants would be randomly assigned to a placebo (a sugar pill) while the other half would take the real Truvada. All participants are aware that they may not be taking the real medication and are counseled regularly and provided condoms and testing for all sexually transmitted infections to lower their risk of HIV infection.
Despite all the prevention measures, there is a chance some participants could become HIV infected during the trial. To ensure that infected participants are quickly referred to the best available medical and psychosocial services, they receive free rapid HIV testing at every monthly visit. Participants who become infected will receive confirmatory testing for infection, post-test risk-reduction and support counseling, as well as help enrolling in local HIV care programs, such as antiretroviral treatment.
Tlou said the hope is that the trial results in a prevention method that can be used safely by both men and women, which is especially important to those women who are unable to negotiate condom use.
"It may provide the first possibility of self-protection at a time when the HIV scourge in Botswana and in the rest of sub-Saharan Africa is wearing a woman's face," Tlou said. "The hardest hit section of our population is women in all age groups."
The Botswana trial is running in conjunction with similar pre-exposure
prophylaxis, or PrEP, trials in the United States and Thailand. All
procedures and plans for the three trials were reviewed and approved by
scientific and ethical review committees at CDC as well as by ethic
committees established by each host country. Additionally, data on safety,
enrollment, and efficacy will be reviewed at standard intervals by an
independent data safety and monitoring board (DSMB) for the Botswana trial.