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Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

NCT02720094 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 4570

Last updated 2026-03-19

Study results available
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Summary

This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).

Conditions

  • HIV Infections

Interventions

DRUG

Cabotegravir Oral Tablet

30 mg tablet

DRUG

TDF/FTC tablets

300 mg/200 mg fixed-dose combination tablets

DRUG

Placebo for TDF/FTC tablets

DRUG

Placebo for cabotegravir oral tablet

DRUG

CAB LA

Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

DRUG

Placebo for CAB LA

Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Raphael J. Landovitz, MD, MSc · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2020-05-14
Completion
2025-03-31

Countries

  • United States
  • Argentina
  • Brazil
  • Peru
  • South Africa
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

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 NCT02720094 on ClinicalTrials.gov