Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT03164564

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

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions HIV Infections

Interventions CAB LA Oral CAB Oral TDF/FTC Placebo for CAB LA Placebo for oral CAB Placebo for oral TDF/FTC

Updated 21 times since 2017 Last updated: Sep 23, 2025 Started: Nov 7, 2017 Primary completion: Nov 5, 2020 Completion: Oct 17, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03164564, this PHASE3 trial focuses on HIV Infections and remains ongoing. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 21 times since 2017, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

21 versions recorded

Nov 2025 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Nov 2025 [monthly]

Active Not Recruiting PHASE3
Oct 2024 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Sep 2024 — Oct 2024 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3

▶ Show 16 earlier versions

Apr 2023 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
Dec 2021 — Apr 2023 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jan 2021 — Dec 2021 [monthly]

Recruiting PHASE3
Sep 2020 — Jan 2021 [monthly]

Recruiting PHASE3
Dec 2019 — Sep 2020 [monthly]

Recruiting PHASE3
Dec 2018 — Dec 2019 [monthly]

Recruiting PHASE3
Nov 2018 — Dec 2018 [monthly]

Recruiting PHASE3
Oct 2018 — Nov 2018 [monthly]

Recruiting PHASE3
Aug 2018 — Oct 2018 [monthly]

Recruiting PHASE3
Jul 2018 — Aug 2018 [monthly]

Recruiting PHASE3
Jun 2018 — Jul 2018 [monthly]

Recruiting PHASE3
May 2018 — Jun 2018 [monthly]

Recruiting PHASE3
Jan 2018 — May 2018 [monthly]

Recruiting PHASE3
Dec 2017 — Jan 2018 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Nov 2017 — Dec 2017 [monthly]

Not Yet Recruiting PHASE3
Jun 2017 — Nov 2017 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Institute of Allergy and Infectious Diseases (NIAID)

Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Blantyre, Malawi , Cape Town, South Africa , Chitungwiza, Zimbabwe , Durban, South Africa , Entebbe, Uganda , Gaborone, Botswana , Harare, Zimbabwe , Isipingo, South Africa , Johannesburg, South Africa , Kampala, Uganda and 4 more locations