Evaluating the Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Healthy, HIV-Uninfected Adolescents (CHAMPS Pilot Study B)
Status:Ongoing
Phase:II
Principal Investigator(s):Linda-Gail Bekker, MBChB, PhD
Objective:Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of age.
Prevention Option(s):PrEP
Study Design:Open label
Arms and Assigned Interventions
DescriptionAll participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.
Mode of DeliveryTablet
ARMsExperimental
Official Code:
NCT02213328
Trial Sponsors:
NIAID
Start Date
End Date
April 1, 2015
April 19, 2017
Enrollment:150
Age range:
15 Years ↔
19 Years
Population: