Clinical Trial Launched With Hopes of Discovering New Prevention
Method
With
more than 300,000 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 working hard to answer that call.
On May 4th, 2007, BOTUSA launched a new landmark study to determine whether
taking a daily antiretroviral pill can prevent HIV infection among healthy
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 clinical study, called the TDF2 HIV Prevention Trial, was launched in
Gaborone with a goal of recruiting 1,200 young Batswana adults between ages
18-29 who are not infected with HIV.
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 well-being 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.
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
transmission 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. Poloko Kebaabetswe, a co-principal investigator, said that 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, Thailand, Puru and
Ecuador. All procedures and plans for the trials have been 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.
For more information on the trial, contact Kebaabetswe at +267 319-1375 in
Gaborone and +267 241-0646 in Francistown. |