CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 3,224 enrolled
Drug / intervention
Oral CAB +5 moredrug
Likely dose
Oral CAB 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/NCT03164564
NCT03164564Phase 3Active
CompareCT.gov

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 23, 2017·Updated Oct 9, 2025

In Brief

A Phase 3 clinical trial evaluating Oral CAB, Oral TDF/FTC, and 4 other interventions for HIV Infections. Active but no longer recruiting, targeting 3,224 participants across 20 sites in 7 countries.

Detailed Summary

This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, Eswatini, Kenya, Malawi, South Africa, Uganda, Zimbabwe
Collaborators--

Timeline

Phase 3Active
2018201920202021202220232024202520262027
First PostedMay 23, 2017
Enrollment StartNov 7, 2017
Primary CompletionNov 5, 2020
Study CompletionOct 17, 2026
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.1 years ago

Interventions

Oral CABdrug

CAB 30 mg tablet

Oral TDF/FTCdrug

TDF/FTC 300 mg/200 mg fixed dose combination tablet

Placebo for oral CABdrug

Placebo tablets

Placebo for oral TDF/FTCdrug

Placebo tablets

CAB LAdrug

600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle

Placebo for CAB LAdrug

Administered as one 3 mL intramuscular injection in the gluteal muscle