TDF-2

Dr. Malotte, CHER Director, was a co-investigator for a project entitled, “Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana (TDF-2).” The purpose of this trial was to determine whether antiretroviral medication (in this case the drug Truvada) taken as daily oral prophylaxis (pre-exposure prophylaxis or PrEP) is safe on a long-term basis and whether it significantly reduces the rate of acquisition of HIV infection when used in addition to standard risk reduction methods. Participants in this study were randomized to receive either the antiretroviral medication or its placebo and were followed for any adverse effects of the agent, any changes in their sexual risk behavior, and HIV incidence. Dr. Malotte assisted in the development of risk-reduction, support, and adherence counseling guidelines and in the training and observation of counseling staff. The results of this trial, indicating a reduction of HIV acquisition of approximately 63% among those on PrEP, generated worldwide press coverage, and the results of this and several other trials were used by the United States Food and Drug Administration in their decision to approve Truvada for prevention of HIV infection. An article in the New England Journal of Medicine describes the study and its outcomes.