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

NCT03164564 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3224

Last updated 2025-10-09

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Oral CAB

CAB 30 mg tablet

DRUG

Oral TDF/FTC

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

DRUG

Placebo for oral CAB

Placebo tablets

DRUG

Placebo for oral TDF/FTC

Placebo tablets

DRUG

CAB LA

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

DRUG

Placebo for CAB LA

Administered as one 3 mL intramuscular injection in the gluteal muscle

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sinead Delany-Moretlwe, PhD, DTM&H · Wits Reproductive Health and HIV Institute CRS (WRHI CRS)

  • Mina Hosseinipour, MD, MPH · University of North Carolina (UNC) Project-Malawi, Tidziwe Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2020-11-05
Completion
2026-10-17
FDA Drug
Yes

Countries

  • Botswana
  • Eswatini
  • Kenya
  • Malawi
  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03164564 on ClinicalTrials.gov