Clinical Trial

Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2017-05-22; most recent amendment 2025-09-23.
Status change: Recruiting → Active, Not Recruiting 2021-11-02
Status change: Not Yet Recruiting → Recruiting 2017-11-29
Trial Details
NCT Number NCT03164564
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions HIV Infections
Enrollment 3,224 participants
Start Date 2017-11-07
Primary Completion 2020-11-05 (estimated)
Study Completion 2026-10-17 (estimated)
Updated on ClinicalTrials.gov 2025-10-09