| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03188523 | Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002) | PHASE1 | COMPLETED | 12 | — | — | Sep 8, 2017 | Jun 4, 2018 | Jul 15, 2019 | 2 | Germany, United Kingdom |
Plasma samples were collected from participants after a single dose of MK-8504 to assess viral load. The log10 plasma HIV-RNA (copies/mL) measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. Change from baseline to 168 hours post-dose was determined for each treatment group. Results are expressed as change in HIV RNA log10 (copies/mL).
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants experiencing at least one AE was reported for each arm.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants that discontinued study treatment due to an AE was reported for each arm.
| Arm | Type | Description |
|---|---|---|
| MK-8504 100 mg (Panel A) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 100 mg. |
| MK-8504 240 mg (Panel B) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 240 mg. |
| MK-8504 ≤240 mg (Panel C) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 ≤240 mg. |
| MK-8504 ≤240 mg (Panel D) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 ≤240 mg. |
| Name | Type | Description |
|---|---|---|
| MK-8504 | DRUG | After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form. |
Inclusion Criteria: * Male or non-pregnant and non-breast feeding female * Have a Body Mass Index (BMI) ≤35 kg/m\^2 * Other than HIV infection, have stable baseline health based on medical history, physical examination, vital sign measurements, and laboratory safety test * Is documented HIV-1 posit...