TDF2

Status:Completed
Phase:III, II
Principal Investigator(s):Lynn Paxton, MD
Objective:Tested whether daily TDF/FTC (Truvada) was safe for HIV-negative sexually-active young adults in Botswana and whether it reduced risk of HIV infection.Key results: 62% Reduction in HIV infection rate on Daily oral TDF/FTC among heterosexual males and females in Botswana, underpowered for sex differences. Last updated August 10, 2022
Prevention Option(s):PrEP
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionDaily dosing
Mode of Delivery
ARMsExperimental
Results: Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.
Official Code: NCT00448669
Related Publications:
Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana.
CD4(+) cell count, viral load, and drug resistance patterns among heterosexual breakthrough HIV infections in a study of oral preexposure prophylaxis.
Evaluation of Sexual Risk Behavior Among Study Participants in the TDF2 PrEP Study Among Heterosexual Adults in Botswana
Normal laboratory reference intervals among healthy adults screened for a HIV pre-exposure prophylaxis clinical trial in Botswana
Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010
Trial Sponsors: Botswana Ministry of Health, CDC
Start Date
End Date
March 31, 2007
March 31, 2011
Enrollment:1,219
Age range: 18 Years ↔ 39 Years
Population:Cisgender Men, Cisgender Women