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

Phase 1

• Conditions: HIV Preexposure prophylaxis; MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003309-79-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1399
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator.
2. Findings of chronic HBV (HBsAg-positive) or past HBV (HBsAg-negative and HBcAb-positive) infection which could indicate risk for hepatitis B reactivation.
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.
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 anal cancers.
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, lenacapavir, or any other long-acting HIV prevention product at any time (past or current).
7. Is currently receiving or is anticipated to require any prohibited therapies outlined in the protocol from 30 days prior to Day 1 through the duration of the study.
8. Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device within 30 days prior to Day 1 through the duration of the study.
9. Has exclusionary laboratory values within 45 days prior to Day 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1 infection relative to the background rate.<br>2. To evaluate the safety and tolerability of oral ISL QM compared to FTC/TDF or FTC/TAFQD as assessed by review of the accumulated safety data.;Secondary Objective: 1. To compare the incidence rate per year of confirmed HIV-1 infections following administration of ISL QM and FTC/TDF or FTC/TAF QD.;Primary end point(s): 1. Incidence Rate Per Year of Confirmed Human Immunodeficiency Virus 1 (HIV- 1) infection<br>2. Percentage of Participants Who Experienced an Adverse Event (AE)<br>3. Percentage of Participants Who Discontinued Study Treatment Due to an AE;Timepoint(s) of evaluation of this end point: 1. Up to approximately 24 months<br>2. Up to approximately 26 Months<br>3. Up to approximately 24 Months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence Rate Per Year of Confirmed HIV-1 infection Among Participants;Timepoint(s) of evaluation of this end point: 1. Up to approximately 24 months