MK8591-024: Oral ISL QM as PrEP in MSM and TGW at High Risk for HIV-1 Infectio

Phase 3

• Conditions: HIV/AIDS

• Registration Number: PACTR202109759050023
• Lead Sponsor: MSD Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion Criteria

1. Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator.
2. Has active HBV infection (defined as HBsAg-positive or HBV DNA positive).
3. Has known current or chronic history of liver disease (eg, nonalcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction.
5. Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to enroll.
6. Has taken cabotegravir at any time (past or current).
Is currently receiving or is anticipated to require any prohibited therapies outlined in Section 6.5 of the study protocol from 30 days prior to Day 1 through the duration of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Confirmed HIV-1 infection 2. AEs and AEs leading to discontinuation of study intervention

Secondary Outcome Measures

Name	Time	Method
Confirmed HIV-1 infection