Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07071623 | A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) | PHASE3 | RECRUITING | 4,580 | — | — | Nov 10, 2025 | Oct 18, 2027 | Jun 1, 2026 | 30 | Kenya, South Africa +1 |
| NCT07044297 | A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | PHASE3 | RECRUITING | 4,390 | — | — | Jul 31, 2025 | Jul 22, 2027 | Jun 8, 2026 | 81 | United States, Argentina +14 |
| NCT07600775 | A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019) | PHASE1 | NOT YET_RECRUITING | 14 | — | — | Jun 22, 2026 | Dec 22, 2026 | May 22, 2026 | - | — |
| NCT06783192 | A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE) | PHASE1 | COMPLETED | 14 | — | — | Aug 14, 2023 | Oct 11, 2023 | Jan 20, 2025 | 1 | United States |
The number of participants with adjudicated HIV-1 infection will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be presented.
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma.
| Arm | Type | Description |
|---|---|---|
| MK-8527 + Placebo to FTC/TDF | EXPERIMENTAL | Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| FTC/TDF + Placebo to MK-8527 | ACTIVE_COMPARATOR | Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| MK-8527 | EXPERIMENTAL | Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to FTC/TDF once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| FTC/TDF | ACTIVE_COMPARATOR | Participants will receive 200 mg FTC/245 mg TDF QD and placebo to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| MK-8527 + Rifampin | EXPERIMENTAL | Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin. |
| Arm 1: All Participants | EXPERIMENTAL | Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527. |
| Name | Type | Description |
|---|---|---|
| MK-8527 | DRUG | Oral tablet |
| Emtricitabine/tenofovir disoproxil (FTC/TDF) | DRUG | Oral tablet |
| Placebo matched to MK-8527 | DRUG | Placebo oral tablet matched to MK-8527 |
| Placebo matched to FTC/TDF | DRUG | Placebo oral tablet matched to FTC/TDF |
| FTC/TDF | DRUG | Oral tablet |
| Placebo to MK-8527 | DRUG | Placebo tablet matched to MK-8527 |
| Placebo to FTC/TDF | DRUG | Placebo tablet matched to FTC/TDF |
| Rifampin | DRUG | Administered orally |
| LNG/EE | DRUG | LNG/EE combination tablet taken by mouth. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results * Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) withi...