Clinical trial

Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and…

NCT02720094 · National Institute of Allergy and Infectious Diseases (NIAID), NIH · Completed

Key facts

NCT number NCT02720094
Title Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
Official title 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
Lead sponsor National Institute of Allergy and Infectious Diseases (NIAID), NIH
Collaborators ViiV Healthcare Industry Gilead Sciences
Status Completed
Phase Phase 2/Phase 3
Study type Interventional
Conditions HIV Infections
Intervention type Drug
Interventions Cabotegravir Oral Tablet, TDF/FTC tablets, Placebo for TDF/FTC tablets, Placebo for cabotegravir oral tablet, CAB LA, Placebo for CAB LA
Enrollment 4,570
Start date Dec 19, 2016
Primary completion May 14, 2020
Completion Mar 31, 2025
First posted Mar 25, 2016
Last update posted Oct 10, 2025
Countries Argentina, Brazil, Peru, South Africa, Thailand, United States, Vietnam

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About ClinicalTrials.gov studies

ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.

Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

Browse all ClinicalTrials.gov studies