CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,570 enrolled
Drug / intervention
Cabotegravir Oral Tablet +5 moredrug
Likely dose
Cabotegravir Oral Tablet 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02720094
NCT02720094Phase 3Completed
CompareCT.gov

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 25, 2016·Updated Mar 19, 2026

In Brief

A Phase 3 clinical trial evaluating Cabotegravir Oral Tablet, TDF/FTC tablets, and 4 other interventions for HIV Infections. Completed, enrolled 4,570 participants across 43 sites in 7 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Brazil, Peru, South Africa, Thailand, United States, Vietnam
CollaboratorsViiV Healthcare, Gilead Sciences

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 25, 2016
Enrollment StartDec 19, 2016
Primary CompletionMay 14, 2020
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.3 years ago

Interventions

Cabotegravir Oral Tabletdrug

30 mg tablet

TDF/FTC tabletsdrug

300 mg/200 mg fixed-dose combination tablets

Placebo for TDF/FTC tabletsdrug

Placebo for cabotegravir oral tabletdrug

CAB LAdrug

Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Placebo for CAB LAdrug

Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter