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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
Randomized
Double-blind
Arms and Assigned Interventions
Description
Daily dosing
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Daily dosing
ARMs
Placebo Comparator
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, US Centers for Disease Control
Product Developers
Gilead Sciences, Inc.
March 2007
March 2011
Date of Enrollment Completion
March 1, 2011
Enrollment
1 219
18
Years
39
Years
Population
Men
Women
Sites

BOTUSA HIV Prevention Research Unit

Francistown and Gaborone
Botswana