HIV/AIDS
Conditions
Interventions
Sponsors
MSD Pty Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. 2. Is a cisgender man, TGW (assigned male sex at birth), TGM {assigned female sex at birth), or GNB person. 3. Has had condomless receptive anal sex in the 12 months prior to screening {not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: • Receptive anal sex with 2 or more partners in the 3 months prior to screening {regardless of condom use)• Rectal or urethral gonorrhoea or chlamydia or incident syphilis in the 6 months prior to screening • Any self-reported stimulant drug use with sex in the 3 months prior to screening 4. Is <?16 years of age at the time of providing the informed consent or assent, as applicable. Note: Enrollment for 16- to 17-year-old participants may begin only after completion and review of the initial safety review results by the eDMC. 5. Weighs less 35 kg at enrollment 6. A participant assigned female sex at birth is eligible to participate if not breast/chest feeding. 7. A POCBP is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test {urine or serum), as required by local regulations, has been obtained within 24 hours {for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. 8. A POCBP is eligible to participate if they use an acceptable contraceptive method or if they adhere to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) 9. The participant (or participant's legally acceptable representative) has provided documented informed consent and the participant has provided documented assent, when applicable, for the study. 10. Has no plans to relocate or travel away from the site that would interfere with attending monthly on-site visits
Exclusion criteria
Exclusion criteria: 1. Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator. 2. Has evidence of acute or chronic hepatitis B infection (HBsAg positive). 3. Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. 4. Has a history or current evidence of any condition (eg, active tuberculosis infection or hepatic cirrhosis), therapy, laboratory abnormality or other circumstance {including substance or alcohol use disorder) 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. 5. Has taken cabotegravir, lenacapavir, or any other longacting HIV prevention product at any time (past or current use). 6. Is currently receiving or is anticipated to require any prohibited therapies outlined in Section 6.5 from 30 days prior to Day 1 through the study duration (ie, up to 56 ±5 days following the last dose of blinded monthly study intervention). 7. Has received an HIV vaccine at any time {ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1. 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 as listed in Table 1 of the protocol. 10. Is expecting to donate eggs at any time during the study. 11. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adjudicated HIV-1 infection -Adverse events -Adverse events leading to discontinuation of study intervention | — |
Countries
South Africa
Contacts
Public ContactSue Bailey
Clinical Research Director
Outcome results
None listed