HIV/AIDS
Conditions
Interventions
ISL Parallel Different groups receive different interventions at same time during study
Placebo to ISL Parallel Different groups receive different interventions at same time during study
FTC TDF Parallel Different groups receive different interventions at same time during study
Placebo to FTCTDF Parallel Different groups receive different interventions at same time duringstudy
Sponsors
MSD Pty Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization. Note: If a positive result is obtained for any HIV test prior to randomization, the participant is not eligible for the study. Additional testing to confirm suspected HIV infection during screening will be performed in accordance with local guidelines. If HIV infection is confirmed, participants will be referred for appropriate care, as necessary. 2. Has been sexually active with a male sexual partner in the 30 days prior to Screening. 3. Is at high risk for HIV-1 infection as defined by a risk score =5 using a VOICE risk score tool (ex-US sites) or meets the CDC criteria for PrEP eligibility (US sites). Demographics 4. Was assigned female sex at birth, is cisgender, 16 years to 45 years of age, inclusive, at the time of providing informed consent/assent. Female Participants 5. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP OR • Is a WOCBP and using an acceptable contraceptive method, as described in Appendix 5 during the intervention period and for at least 42 days after the last dose (corresponding to the time needed to eliminate any study intervention [approximately 5 terminal halflives]). • A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours 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. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early
Exclusion criteria
Exclusion criteria: 1. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 2. Has active HBV infection (defined as HBsAg-positive or HBV DNA positive) Note: Past HBV infection or previous HBV vaccination (defined as HBsAg-negative and positive for antibody against HBsAg) is not an exclusion criterion. Note: Participants who do not demonstrate immunity to HBV are encouraged to be vaccinated against HBV. 3. 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 significant hepatic synthetic dysfunction. Note: Hepatic synthetic dysfunction is defined as a serum albumin 1.7 in the absence of another explanation for the abnormal laboratory value. 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 cervical cancer. 5. Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use 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. Prior/Concomitant Therapy 6. Has taken cabotegravir at any time (past or current use) 7. 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 duration of the study. Note: Participants taking FTC/TDF for PrEP at screening may continue their regimen until the day of randomization. Also, any prior or current HIV PrEP medications taken by the participant,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Confirmed HIV-1 infection 2. AEs and AEs leading to discontinuation of study intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed HIV-1 infection | — |
Countries
Malawi, South Africa, Swaziland, Uganda, Zambia
Contacts
Public ContactZoe Nell
Clinical Research Director
Outcome results
None listed