HPTN 083
Status:Stopped Early
Phase:III, IIb
Principal Investigator(s):Raphael J. Landovitz, MD, MSc
Objective:This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). For a diagram of the trial schema, click here.May 18, 2020: Based on interim analysis by the Data and Safety Monitoring Board (DSMB), the blinded, randomized portion of the trial will be stopped early for efficacy. Participants who were in the FTC/TDF arm will be offered CAB LA and participants in the CAB LA arm will continue to receive it. July 7, 2020: CAB and TDF/FTC were both safe and highly effective for PrEP in HPTN 083, with estimated incidence in the CAB arm 66% lower than in the TDF/FTC arm. Last updated Dec 23, 2021
Prevention Option(s):PrEP
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionArm A: In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo. In Step 3, participants will receive daily oral TDF/FTC no later than 8 weeks after the last injection, for up to 48 weeks.
Mode of DeliveryIntermuscular, Tablet
ARMsExperimental
DescriptionArm B: In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA. In Step 3, participants will receive daily oral TDF/FTC no later than 8 weeks after the last injection, for up to 48 weeks.
Mode of DeliveryIntermuscular, Tablet
ARMsExperimental
Official Code:
NCT02720094
Trial Sponsors:
Gilead, NIAID, ViiV
Start Date
End Date
December 20, 2016
March 22, 2022
Enrollment:4,570
Age range:
18 Years ↔
any
Population:Gay and Bisexual Men Who Have Sex with Men