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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,224 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to evaluate the safety and efficacy of the long-acting injectable integrase inhibitor cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in a population of sexually active HIV-uninfected women at risk for HIV. This study will take place in three steps. Participants will be randomly assigned to one of two arms: Arm A: Step 1: Participants will receive daily oral CAB and TDF/FTC placebo for 5 weeks. Step 2: Participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily TDF/FTC placebo beginning at Week 5. Arm B: Step 1: Participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. Step 2: Participants will receive daily TDF/FTC and intramuscular (IM) placebo injections at two time points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. Step 2 will continue until the last enrolled participant reaches approximately 76 weeks on Step 2 (Week 81 for the last enrolled participant). In Step 3, all participants (Arms A and B) will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. At the end of Step 3, all participants will then transition to locally available HIV prevention services, including services for PrEP, if available. Study visits will occur at Day 0 and at Weeks 2 and 4 during Step 1. During Step 2, participants will attend up to 24 visits, depending on when they enroll in the study. Study visits will occur every 12 weeks during Step 3. Study visits may include physical examinations; blood, urine, and vaginal swab collection; risk reduction, adherence counseling, and contraception counseling. HPTN 084-01 is a sub-study of HPTN 084. The purpose of this study is to examine the safety, tolerability, and acceptability of CAB LA for the prevention of HIV among adolescent females. Participants will receive oral CAB for 5 weeks, followed by 34 weeks on CAB LA, then quarterly visits for 48 weeks after final injection. All participants who have received at least one injection will be followed for 48 weeks after their last injection. Total study duration per participant will be approximately 21 months.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-07
• Primary completion: 2020-11-05
• Completion: 2026-10-17
• First posted: 2017-05-23
• Last updated: 2025-10-09
• Results posted: 2023-03-28

Locations

20 sites across 7 countries: Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study