Prep is a therapy taken to prevent, rather than to treat, an infection or illness, and it is one strategy being studied by the University of Cape Town’s Desmond Tutu HIV Foundation, as part of its effort to develop new HIV prevention tools.
This study is designed to determine whether a once daily oral dose of the HIV antiretroviral drug Truvada (tenofovir disoproxil fumarate and emtricitabine) will provide additional protection against HIV infection when combined with risk reduction and condom use counseling.
The study will enroll 200 healthy, sexually active, HIV-negative men who have sex with men (MSM) who are at high risk of HIV infection. Potential volunteers will be extensively interviewed to ensure that they understand the study and that their participation is completely voluntary. Consenting study participants will be carefully monitored throughout the 24-month study period and for 6 months afterwards. All study participants will receive condoms and counseling on how to prevent HIV infection, and medical care for any sexually transmitted infections on a monthly basis.
Approximately half will also receive the study drug Truvada once daily, and half will receive a placebo. Neither the study personnel nor the volunteers will know who is receiving the drug and who is receiving placebo. In addition to extensive safer sex counseling, volunteers will be counseled that, even if they receive the study drug, there is no assurance that the drug will offer any protection against HIV infection and that safer sex precautions should always be used.
Truvada was selected for the Cape Town Prep study because it has been shown to be a safe and effective treatment for HIV, with few side effects in studies involving more than 15 000 people worldwide. The tenofovir plus emtricitabine drug combination of Truvada was approved for use by the Food and Drug Administration in the United States in 2004, and in South Africa by the Medicine Control Council in 2007. More than 100 000 HIV-infected people around the world have now used these drugs.
The National Institutes of Health and the Bill and Melinda Gate Foundation are sponsoring the Cape Town Prep study through a grant to the J. David Gladstone Institutes, a non-profit independent research organization affiliated with the University of California, San Francisco.
The Desmond Tutu HIV Foundation is a registered non-profit organization that has developed a robust HIV prevention research agenda focusing on disenfranchised population – particularly young women and MSM.