| Primary | Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL) | The AUC0-24 of ISL in plasma was determined at steady state. | A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*µmol/L | | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Maximum Plasma Concentration (Cmax) of ISL | The Cmax of ISL in plasma was determined at steady state. | A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µmol/L | | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of ISL | The Tmax of ISL in plasma was determined at steady state. | A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters. | Posted | | Median | Full Range | hours | | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Apparent Plasma Terminal Half-life (t½) of ISL | The t½ of ISL in plasma was determined at steady state. | A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Apparent Total Clearance From Plasma (CL/F) of ISL | The CL/F of ISL from plasma was determined at steady state. | A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL | The Vz/F of ISL was determined at steady state. | A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs) | The AUC0-24 of ISL-TP in PBMCs was determined at steady state. | A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*pmol/10^6 cells | | Pre-dose, and 4 and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Cmax of ISL-TP in PBMCs | The Cmax of ISL-TP in PBMCs was determined at steady state. | A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | | Pre-dose, and 4, and 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | C24 of ISL-TP in PBMCs | The C24 of ISL-TP in PBMCs was determined at steady state. | A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | | 24 hours post-dose on Day 28 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Number of Participants Experiencing ≥1 Adverse Event (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. | All participants who received ≥1 dose of study intervention are included. | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | | OG001 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Primary | Number of Participants Discontinuing From Study Treatment 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. | All participants who received ≥1 dose of study intervention are included. | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | | OG001 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL | The percentage of VS participants with HIV-1 RNA ≥50 copies/mL was determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL. | Participants who were VS at baseline (on stable combination antiretroviral therapy [ART] for ≥3 months) and had data available are included. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Percentage of VS Participants With HIV-1 RNA <50 Copies/mL | The percentage of VS participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. | Participants who were VS at baseline (on stable combination ART for ≥3 months) and had data available are included. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL | The percentage of TN participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. | Participants who were TN at baseline and had data available are included. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants | CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts. | All VS participants who received ≥1 dose of study intervention and had data available are included. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Baseline (Day 1) and Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Change From Baseline in CD4+ T-cells in TN Participants | CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts. | TN participants who received ≥1 dose of study intervention and had baseline and Week 24 data available are included. | Posted | | Number | 95% Confidence Interval | cells/mm^3 | | Baseline (Day 1) and Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Incidence of Viral Drug Resistance to DOR | The number of participants with viral drug resistance to DOR was determined. | Participants who received ≥1 dose of study intervention are included. | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | | OG001 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Incidence of Viral Drug Resistance to ISL | The number of participants with viral drug resistance to ISL was determined. | Participants who received ≥1 dose of study intervention are included. | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | | OG001 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Palatability of DOR/ISL Tablet | The palatability of the DOR/ISL tablet (whole or split) was assessed with a modified 5-point facial hedonic scale. Responses ranged from 1 ("very bad") to 5 ("very good"). Data show the number of VS and TN participants responding at each score at the designated time points. | All VS and TN participants who received ≥1 dose of study intervention and have data available are included. | Posted | | Count of Participants | | Participants | | Baseline (Day 1), Week 4, and Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | | OG001 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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| Secondary | Acceptability of DOR/ISL Tablet | The acceptability of the DOR/ISL tablet (whole or split) was assessed. Acceptability was assessed by monitoring for refusing the tablet, throwing up or spitting out the tablet, and gagging on the tablet. Data show the number of VS and TN participants responding at each score at the designated time points. | All VS and TN participants who received ≥1 dose of study intervention and have data available are included. | Posted | | Count of Participants | | Participants | | Baseline (Day 1), Week 4, and Week 24 | | | | ID | Title | Description |
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| OG000 | DOR/ISL: Virologically Suppressed Cohort | VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | | OG001 | DOR/ISL: Treatment Naive Cohort | TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. |
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