A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection

About this Study

To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed HIV-1 infections in women.

Sponsor Protocol ID:MK-8591
IRB Number:2020V0276
Actively Enrolling
Phase 3
October 26, 2021
Eligibility Criteria
16 years old
45 years old
Both Male and Female

Inclusion Criteria1. Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization.

 2. Has been sexually active with a male sexual partner in the 30 days prior to Screening.

3. Was assigned female sex at birth, is cisgender, 16 years to 45 years of age, inclusive, at the time of providing informed consent/assent. 

4. A female participant is eligible to participate if she is not pregnant or breastfeeding,

5. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.

6. Has no plans to relocate or travel away from the site for ≥4 consecutive weeks during study participation.

Exclusion Criteria1. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.

2. Has active HBV infection.

3. Current or chronic history of liver disease.

4. Has a history of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer.

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Infectious Diseases
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Courtney Gomillia
Email: cgomillia@umc.edu
Principal Investigator:Leandro Mena
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