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 Men and Transgender Women Who Have Sex With Men, and Are 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.

Sponsor Protocol ID:MK-8591-022
IRB Number:2020V0356
Actively Enrolling
Phase 3
October 26, 2021
Eligibility Criteria
16 years old
Both Male and Female

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

 2. Is sexually active with male (assigned male sex at birth) or transgender female partners defined as having anal sexual intercourse with a man or TGW at least once in the past month.

3. Is at high risk for sexually acquiring HIV-1 infection based on self-report of at least 1 of the following: 
 Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship 
 More than 5 partners (anal intercourse) in the 6 months prior to screening (regardless of condom use and HIV serostatus, as reported by the enrollee) 
 Any unprescribed stimulant drug use in the 6 months prior to screening 
 Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening

4. Is cisgender male or transgender female (assigned male sex at birth), and ≥16 years of age at the time of providing informed consent/assent.

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 component of the study interventions as determined by the investigator.

 2. Has active HBV infection

3. Has known current or chronic history of liver disease

4. Has taken cabotegravir at any time (past or current).

5. Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device, including HIV-1 prevention compounds or devices, within 30 days prior to Day 1 through the duration of the study. 

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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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