| Primary | Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) Concentration | Plasma was collected at baseline and at 168 hours post-dose to determine the change from baseline in HIV-1 ribonucleic acid (RNA) concentration. The log10 plasma HIV-RNA was measured and analyzed based on a longitudinal data analysis (LDA) model containing fixed effects for dose level and time. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Least Squares Mean | 95% Confidence Interval | log10 copies/mL | | Baseline and 168 hours post-dose | | | | ID | Title | Description |
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| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 | MK-8558 900 mg Low-Fat | Single oral dose of MK-8558 administered at 900 mg following a low-fat meal. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.82(-1.42 to -0.21)
- OG001-1.00(-1.61 to -0.39)
- OG002-1.61(-2.16 to -1.06)
- OG003
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL. | | | | | Posterior Mean Difference | -0.79 | | | | | | | | | Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 2.44 %. | | Superiority | Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants. |
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| Primary | Number of Participants Experiencing ≥1 Adverse Event (AE) | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | All participants who received at least one dose of treatment. | Posted | | Count of Participants | | Participants | | Up to 35 days post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 | MK-8558 900 mg Low-Fat | |
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| Primary | Number of Participants Who Discontinued From the Study Due to an AE | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | All participants who received at least one dose of treatment | Posted | | Count of Participants | | Participants | | Up to 35 days post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 | MK-8558 900 mg Low-Fat | |
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| Secondary | Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) for MK-8558 in Plasma | Plasma was collected from pre-dose up to 168 hours post-dose in order to determine the AUC0-168 for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μM | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 |
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| Secondary | Area Under the Concentration-Time Curve From 0 up to the Last Quantifiable Time-Point (AUC0-last) for MK-8558 in Plasma | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the AUC0-last for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μM | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | |
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| Secondary | Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) for MK-8558 in Plasma | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the AUC0-inf for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μM | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | |
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| Secondary | Maximum Observed Concentration (Cmax) for MK-8558 in Plasma | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the Cmax for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μM | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 |
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| Secondary | Time to Maximum Observed Concentration (Tmax) for MK-8558 in Plasma | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the Tmax for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Median | Full Range | Hours | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 | MK-8558 900 mg Low-Fat |
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| Secondary | Concentration at 168 Hours Post-Dose (C168hr) for MK-8558 in Plasma | Plasma was collected at 168 hours post-dose in order to determine the C168hr for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μM | | 168 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 | MK-8558 900 mg Low-Fat |
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| Secondary | Apparent Clearance (CL/F) for MK-8558 | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the CL/F for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 |
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| Secondary | Apparent Volume of Distribution (Vz/F) for MK-8558 | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the Vz/F for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 |
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| Secondary | Terminal Half Life (t1/2) for MK-8558 | Plasma was collected from pre-dose up to 504 hours post-dose in order to determine the t1/2 for MK-8558. Data were natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. One participant from the 900 mg treatment group was excluded from analysis due to important protocol deviation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | MK-8558 400 mg | Single oral dose of MK-8558 administered at 400 mg following a 10-hour fast. | | OG001 | MK-8558 900 mg | Single oral dose of MK-8558 administered at 900 mg following a 10-hour fast. | | OG002 | MK-8558 1600 mg | Single oral dose of MK-8558 administered at 1600 mg following a 10-hour fast. | | OG003 |
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