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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002192-28 | EudraCT Number | ||
| MK-8591-003 | Other Identifier | Merck Protocol Number |
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This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5 log (base10) copies/mL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Islatravir 1 mg | Experimental | Single oral dose of islatravir 1 mg |
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| Islatravir 2 mg | Experimental | Single oral dose of islatravir 2 mg |
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| Islatravir 10 mg | Experimental | Single oral dose of islatravir 10 mg |
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| Islatravir 30 mg | Experimental | Single oral dose of islatravir 30 mg |
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| Islatravir 0.5 mg | Experimental | Single oral dose of islatravir 0.5 mg |
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| Islatravir 0.25 mg | Experimental | Single oral dose of islatravir 0.25 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 mg islatravir | Drug | Single oral dose of 1 mg islatravir administered following ≥8 hour fast |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose | Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches. | Baseline and 168 hours (7 days) post-dose |
| Number of Participants With One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 21 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr) | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr. | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31911147 | Derived | Schurmann D, Rudd DJ, Zhang S, De Lepeleire I, Robberechts M, Friedman E, Keicher C, Huser A, Hofmann J, Grobler JA, Stoch SA, Iwamoto M, Matthews RP. Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial. Lancet HIV. 2020 Mar;7(3):e164-e172. doi: 10.1016/S2352-3018(19)30372-8. Epub 2020 Jan 3. |
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Additional panels (F: 0.25 mg islatravir; and G: 30 mg islatravir Extended Observation) were initially planned but were not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A: 10 mg Islatravir | Participants received a single dose of 10 mg islatravir. |
| FG001 | Panel B: 2 mg Islatravir | Participants received a single dose of 2 mg islatravir. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2016 |
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| Islatravir 30 mg Extended Observation | Experimental | Single oral dose of 30 mg islatravir administered following >8 hour fast. Participants will be closely monitored for viral load for up to approximately 21 days prior to starting standard of care ART. |
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| 2 mg islatravir | Drug | Single oral dose of 2 mg islatravir administered following ≥8 hour fast |
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| 10 mg islatravir | Drug | Single oral dose of 10 mg islatravir administered following ≥8 hour fast |
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| 30 mg islatravir | Drug | Single oral dose of 30 mg islatravir administered following ≥8 hour fast |
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| 0.5 mg islatravir | Drug | Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast |
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| 0.25 mg islatravir | Drug | Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast |
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| Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax. | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
| Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr) | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr. | 168 hours after islatravir administration |
| Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax. | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
| Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2. | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
| Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr) | Blood was collected for the determination of AUC0-168hr of islatravir in plasma. | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated. |
| Maximum Plasma Concentration (Cmax) of Islatravir | Blood was collected for the determination of Cmax of islatravir in plasma. | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration |
| Time to Maximum Plasma Concentration (Tmax) of Islatravir | Blood was collected for the determination of Tmax of islatravir in plasma. | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration |
| Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma | Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma. | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration |
| FG002 | Panel C: 30 mg Islatravir | Participants received a single dose of 30 mg islatravir. |
| FG003 | Panel D: 1 mg Islatravir | Participants received a single dose of 1 mg islatravir. |
| FG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
| FG005 | Panel F: 0.25 mg Islatravir | Participants received a single does of 0.25 mg islatravir. |
| FG006 | Panel G: 30 mg Islatravir Extended Observation | Participants received a single does of 30 mg islatravir. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A: 10 mg Islatravir | Participants received a single dose of 10 mg islatravir. |
| BG001 | Panel B: 2 mg Islatravir | Participants received a single dose of 2 mg islatravir. |
| BG002 | Panel C: 30 mg Islatravir | Participants received a single dose of 30 mg islatravir. |
| BG003 | Panel D: 1 mg Islatravir | Participants received a single dose of 1 mg islatravir. |
| BG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Plasma HIV-1 Ribonucleic Acid (RNA) | Mean | Standard Deviation | log10 copies/mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose | Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had available plasma HIV-1 RNA data at baseline and 168 hours post-dose, and were evaluable for the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | log10 copies/mL | Baseline and 168 hours (7 days) post-dose |
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| Primary | Number of Participants With One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | All participants who received at least one dose of investigational drug | Posted | Count of Participants | Participants | Up to 21 days post-dose |
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| Secondary | Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr) | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had AUC0-168hr of triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pmol/10^6 cells | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
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| Secondary | Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Cmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
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| Secondary | Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr) | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had C168hr of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | 168 hours after islatravir administration |
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| Secondary | Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Tmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure. | Posted | Median | Full Range | Hour | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
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| Secondary | Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells | Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample. |
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| Secondary | Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr) | Blood was collected for the determination of AUC0-168hr of islatravir in plasma. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma AUC-168hr of islatravir data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated. |
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| Secondary | Maximum Plasma Concentration (Cmax) of Islatravir | Blood was collected for the determination of Cmax of islatravir in plasma. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Cmax of islatravir data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of Islatravir | Blood was collected for the determination of Tmax of islatravir in plasma. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Tmax of islatravir data available, and were evaluable for the outcome measure. | Posted | Median | Full Range | Hour | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration |
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| Secondary | Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma | Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma. | The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir in plasma data available, and were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration |
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Up to 21 days following administration of investigational drug
All participants who received at least one dose of investigational drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel A: 10 mg Islatravir | Participants received a single dose of 10 mg islatravir. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG001 | Panel B: 2 mg Islatravir | Participants received a single dose of 2 mg islatravir. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | Panel C: 30 mg Islatravir | Participants received a single dose of 30 mg islatravir. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Panel D: 1 mg Islatravir | Participants received a single dose of 1 mg islatravir. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. | 0 | 6 | 0 | 6 | 6 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Oral mucosa erosion | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Sensory disturbance | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Apathy | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| May 2, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C558823 | islatravir |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 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 longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose. | Posterior mean difference | -1.32 | Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%. | 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 longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose. | Posterior mean difference | -1.57 | Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%. | 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 longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose. | Posterior mean difference | -1.28 | Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%. | 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 longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose. | Posterior mean difference | -1.18 | Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%. | Superiority |
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
|
|
| Panel D: 1 mg Islatravir |
Participants received a single dose of 1 mg islatravir. |
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
|
|
Participants received a single dose of 1 mg islatravir. |
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
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Participants received a single dose of 1 mg islatravir.
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
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Participants received a single dose of 1 mg islatravir. |
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
|
|
| Panel D: 1 mg Islatravir |
Participants received a single dose of 1 mg islatravir. |
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
|
|
Participants received a single dose of 1 mg islatravir.
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
|
|
| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
|
|
| OG004 |
| Panel E: 0.5 mg Islatravir |
Participants received a single dose of 0.5 mg islatravir. |
|
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| OG004 | Panel E: 0.5 mg Islatravir | Participants received a single dose of 0.5 mg islatravir. |
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|