PrEP is an experimental strategy. It has not been proven to provide protection against HIV infection. There are four ongoing clinical trials in humans that are designed to provide answers about safety and efficacy. Data from these studies (summarized in the PrEP clinical trials table) are expected as early as 2009.
Clinical trials of experimental medications or prevention strategies in humans begin with small studies that measure safety and, in some cases, markers of activity such as immune responses. These may be followed by larger studies that gather more safety information. Finally, there may be large studies to collect data on efficacy. For more on the clinical trials process, click here. For more on how HIV prevention trials are designed, click here.
In order to get a clear picture of whether PrEP is a viable prevention strategy, data on safety and efficacy are needed on different populations: men who have sex with men, injection-drug users, and heterosexual men and women.
Tenofovir disoproxil fumarate (TDF) and Truvada® (the current drugs being tested in PrEP trials) are both anti-retrovirals (ARVs) that have been approved for use in treating HIV infection. This means these drugs have already been shown to be safe for use in HIV-positive people. However, information on the safety of daily use of these anti-retrovirals among HIV-negative individuals is still needed.
For more information on the scientific rationale behind PrEP for HIV prevention click here.
Ongoing studies will be providing some data on each of these groups, but more studies will be needed to confirm these early answers and to gather additional detail.
To learn more about how HIV-prevention trials are designed, see “The Basics” or click here.
The studies, including their populations, the drugs being tested, the anticipated completion date and other information, are listed in the PrEP Clinical Trials table, which is updated regularly.
For additional reading on PrEP clinical trials, check out the list of resources (left-hand column). |
