| Primary | Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | The PK Substudy Analysis Set included all enrolled and treated participants from Part A who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 4 intensive PK data for the respective analyte. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | PK Parameter: AUCtau of EVG (Cohort 2) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | PK Parameter: AUCtau of EVG (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | The Intensive PK Analysis Set included all enrolled and treated participants who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 2 intensive PK data for the respective analyte. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) | AUClast is defined as the concentration of drug from time zero to the last observable concentration, area under the concentration time curve to last observation (AUClast). | Participants in the PK Substudy Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | PK Parameter: AUClast of TAF (Cohort 2) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Participants in the PK Substudy Analysis set were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | PK Parameter: AUCtau of TAF (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | Participants in the Intensive PK Analysis Set (all enrolled and treated participants who had any nonmissing key PK parameters [AUCtau, AUClast, Cmax] from Week 2 intensive PK data for the respective analyte) with available data were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:
- Fatal
- Life-threatening
- Disabling/incapacitating
- Results in hospitalization or prolongs a hospital stay
- A congenital abnormality
- Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants in the Safety Analysis Set (all participants who received at least 1 dose of study drug) with available data were analyzed. | Posted | | Number | | percentage of participants | | From first dose date up to Week 24 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:
- Fatal
- Life-threatening
- Disabling/incapacitating
- Results in hospitalization or prolongs a hospital stay
- A congenital abnormality
- Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | From first dose date up to Week 24 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Primary | Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:
- Fatal
- Life-threatening
- Disabling/incapacitating
- Results in hospitalization or prolongs a hospital stay
- A congenital abnormality
- Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | From first dose date up to Week 24 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK Substudy Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the Intensive PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | Cmax is defined as the maximum concentration of drug. | Participants in the PK Substudy Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | Cmax is defined as the maximum concentration of drug. | Participants in the PK Substudy Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | Cmax is defined as the maximum concentration of drug. | Participants in the Intensive PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country |
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| Secondary | PK Parameter: CL/F of EVG and TAF (Cohort 1) | Apparent oral clearance (CL/F) is defined as the apparent clearance of the drug following oral administration. | Participants in the PK Substudy Analysis Set with available data were analyzed | Posted | | Mean | Standard Deviation | L/hr | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: CL/F of EVG and TAF (Cohort 2) | CL/F is defined as the apparent clearance of the drug following oral administration. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | L/hr | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: CL/F of EVG and TAF (Cohort 3) | CL/F is defined as the apparent clearance of the drug following oral administration. | Participants in the Intensive PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | L/hr | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country |
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| Secondary | PK Parameter: Vz/F of EVG and TAF (Cohort 1) | Vz/F is defined as the apparent volume of distribution of the drug after oral administration. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | liters | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Vz/F of EVG and TAF (Cohort 2) | Vz/F is defined as the apparent volume of distribution of the drug after oral administration. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | liters | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: Vz/F of EVG and TAF (Cohort 3) | Vz/F is defined as the apparent volume of distribution of the drug after oral administration. | Participants in the Intensive PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | liters | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
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| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | | | | ID | Title | Description |
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| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). | Participants in the Intensive PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | hr*ng/mL | | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | The Full analysis set included all participants who were enrolled in the study and had received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
| |
| Secondary | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | copies/mL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | copies/mL | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/μL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/μL | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 | | Participants in the Full Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | cells/μL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/μL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4+ cell | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4+ cell | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Treatment naive adolescents (12 to < 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 | | Participants in the Full Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4+ cell | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4+ cell | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Children (6 to < 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4+ cell | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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| Secondary | Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4+ cell | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Children (≥ 2 years of age weighing ≥ 14 to < 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. |
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