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

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Cabotegravir Oral Tablet — DRUG
  30 mg tablet
• TDF/FTC tablets — DRUG
  300 mg/200 mg fixed-dose combination tablets
• Placebo for TDF/FTC tablets — DRUG
• Placebo for cabotegravir oral tablet — DRUG
• CAB LA — DRUG
  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
• Placebo for CAB LA — DRUG
  Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

Study Details

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).

Key Dates

First listed

Mar 25, 2016

Start date

Dec 19, 2016

Status verified

Mar 2026

Primary completion

May 14, 2020

Completion

Mar 31, 2025

Study Design

Enrollment

4,570 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Arm A
  In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
• Experimental: Arm B
  In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.

Primary Outcome Measure

Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 [ Time Frame: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. ]

Locations (27)

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