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Islatravir once-monthly for HIV-1 prevention in cisgender women
NCT04644029Phase 3
Key facts
- Status
- Terminated
- Start
- Feb 2021
- Primary completion
- Jul 2023
- Countries
- 3
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- islatravir
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 3, randomised, double-blind trial of islatravir in human immunodeficiency virus type 1 infection (HIV-1) (2 arms), sponsored by Merck & Co. Primary endpoints: Incidence Rate Per Year of Confirmed HIV-1 Infection, Adverse Events and 1 more. Started Feb 2021; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Islatravir Once Monthly
Islatravir 60 mg once monthly + placebo to FTC/TDF once daily during Part 1, then optional open-label FTC/TDF
FTC/TDF Once Daily
FTC/TDF once daily + placebo to islatravir once monthly during Part 1, then continued open-label FTC/TDF
03
Who it enrols
HIV-uninfected cisgender women at high risk for HIV-1 infection, sexually active with male partners, not pregnant or breastfeeding, without hepatitis B or liver disease, and no prior use of long-acting HIV prevention products
04
Endpoints
Primary
Incidence Rate Per Year of Confirmed HIV-1 Infection
Adverse Events
Discontinuation of Study Treatment Due to Adverse Event
Secondary
Incidence Rate Per Year of Confirmed HIV-1 Infection Among ISL-Treated Participants
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