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Cabotegravir LA vs TDF/FTC for HIV PrEP in Women
NCT03164564Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Nov 2017
- Primary completion
- Nov 2020
- Countries
- 7
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Small Molecules
- Drugs
- cabotegravir
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 3, randomised, double-blind trial of cabotegravir in human immunodeficiency virus infection (HIV) (2 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Number of Participants With Documented Incident HIV Infections at 185 weeks and Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 at 81 weeks. Started Nov 2017; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Arm A: CAB + Placebo TDF/FTC + CAB LA
Oral CAB lead-in followed by CAB LA injections every 8 weeks.
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA
Oral TDF/FTC daily throughout Step 1 and Step 2.
03
Who it enrols
HIV-uninfected females at birth, 18-45 years old, sexually active and at risk for HIV, with adequate renal and hepatic function, willing to use reliable contraception.
04
Endpoints
Primary
Number of Participants With Documented Incident HIV Infections
Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2
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