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

JRCT ID: jRCT2031200419

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: HIV Preexposure Prophylaxis
• Date of first enrollment: 06/05/2021
• Target sample size: 1500
• Countries of recruitment: United States of America,Japan,France,Japan,Thailand,Japan,Kenya,Japan,South Africa,Japan,Brazil,Japan,Peru,Japan
• Study type: Interventional

Intervention(s)

MK-8591 60 mg tablet, QM, orally for up to 24 months for up to 24 months
or
FTC/TDF 200/300 mg combination tablet or FTC/TAF 200/25 mg combination tablet, QD, orally for up to 24 months for up to 24 months

Outcome(s)

Primary Outcome

1. Confirmed HIV-1 infection (compare the incidence rate per year of confirmed HIV-1 Infections between the MK-8591 arm participants and the background incidence rate calculated from screened participants.)
2. Adverse events
3. Adverse events leading to discontinuation
of study intervention

• Secondary Outcome: 1. Confirmed HIV-1 infection (compare the incidence rate per year of confirmed HIV-1 infections between the MK-8591 arm and comparator.)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1. Has confirmed Human Immunodeficiency Virus (HIV) uninfected based on negative HIV-1/HIV-2 test result before randomization
2. Is sexually active with male or transgender women (TGW) 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: a) Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship b) More than 5 partners (anal intercourse) in the 6 months prior to screening c) Any unprescribed stimulant drug use in the 6 months prior to screening d) Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening
4. Has no plans to relocate or travel away from the site for >=4 consecutive weeks during study participation

Exclude criteria

1. 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 or known hepatic or biliary abnormalities, 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, therapy, laboratory abnormality or other circumstance 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
7. Is currently receiving or is anticipated to / require any prohibited therapies outlined in the study 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, including HIV-1 prevention compounds or devices, 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

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT04652700