A Phase 3 Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infectio

Phase 1

• Conditions: Prevention of HIV-1 infection; MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001289-39-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

• Study Start: 2021-10-25
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

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

Inclusion Criteria

- Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization.
- Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening.
- High risk for HIV-1 infection.
- Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose.
- A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention.

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 4400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
- Findings of chronic hepatitis B virus (HBV) infection or past HBV.
- Current or chronic history of liver disease.
- History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- Past or current use of cabotegravir, lenacapavir, or any other long-acting HIV prevention product.
- Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1.
- Expecting to conceive or donate eggs at any time during the study

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 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<br>2. To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data<br>;Secondary Objective: To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1 infection relative to the background rate;Primary end point(s): 1. Incidence Rate Per Year of Confirmed HIV-1 Infections <br>2. Percentage of Participants Who Experienced One or More Adverse Events <br>3. Percentage of Participants Who Discontinued Treatment Due to an Adverse Event <br>;Timepoint(s) of evaluation of this end point: 1. Up to approximately 36 months <br>2. Up to approximately 37 months <br>3. Up to approximately 36 months <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Incidence Rate per Year of Confirmed HIV-1 Infections Among Participants;Timepoint(s) of evaluation of this end point: Up to approximately 36 months