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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_542 | |||
| 2010-020829-41 | EudraCT Number |
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This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A - MK6186 40 mg | Experimental | MK6186 40 mg |
|
| Panel A - Placebo | Placebo Comparator | placebo |
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| Panel B - MK6186 150 mg | Experimental | MK6186 150 mg |
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| Panel B - Placebo | Placebo Comparator | placebo |
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| Panel C - MK6186 <=150 mg | Experimental | MK6186 <=150 mg |
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| Panel C - Placebo | Placebo Comparator | placebo |
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| Panel D - MK6186 <=150 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK6186 | Drug | Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma HIV-1 RNA | Baseline and Day 7 | |
| Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences | through Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| C(24 hour) of MK6186 | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39291814 | Result | Schurmann D, Huser A, Pfafflin F, Cilissen C, De Lepeleire I, Larson PJ, Anderson MS, Rizk ML, Hofmann J, Daumer M, Stegemann MS, Stoch SA, Wagner F, Iwamoto M. A Randomized, Double-Blind, Placebo-Controlled, Short-Term Monotherapy Study of MK-6186, an HIV-1 Non-Nucleoside Reverse Transcriptase Inhibitor, in Treatment-Naive HIV-Infected Participants. AIDS Res Hum Retroviruses. 2025 Jan;41(1):11-19. doi: 10.1089/AID.2023.0152. Epub 2024 Oct 3. |
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| Experimental |
MK6186 <=150 mg |
|
| Panel D - Placebo | Placebo Comparator | placebo |
|
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| Comparator: Placebo | Drug | Placebo tablets taken orally for seven day |
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