| Primary | Pharmacokinetic (PK) Parameter: AUCtau of EVG | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Intensive PK Analysis Set(EVG): all enrolled participants who received at least 1 dose of study drug and for whom steady-state pharmacokinetic profiles of the analyte of interest at the Intensive PK(Day 10) visit were evaluable.Includes 12 participants with screening HIV-1 RNA<50 copies/mL and 2 participants with screening HIV-1 RNA>1000 copies/mL. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose and up to 12 hours postdose on Day 10 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 12 Years | PK results were summarized for all participants age 6 to < 12 years as one group. EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg). |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference). | | | | | GLSM Ratio (%) (Test/Reference) | 135.73 | | | 2-Sided | 90 | 116.24 | 158.49 | | | | | Equivalence | A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling). |
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| Primary | Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10 | Cmax is defined as the maximum concentration of drug. | Intensive PK Analysis Set (EVG) | Posted | | Mean | Standard Deviation | ng/mL | | Predose and up to 12 hours postdose on Day 10 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 12 Years | PK results were summarized for all participants age 6 to < 12 years as one group. EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg). |
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| Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events | | | Posted | | Number | | percentage of participants | | Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL) | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Primary | Percentage of Participants Experiencing Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening). | | Posted | | Number | | percentage of participants | | Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL) | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 |
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| Secondary | Pharmacokinetic (PK) Parameter: Ctau of EVG | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Intensive PK Analysis Set (EVG) | Posted | | Mean | Standard Deviation | ng/mL | | Predose and up to 12 hours postdose on Day 10 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 12 Years | PK results were summarized for all participants age 6 to < 12 years as one group. EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg). |
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| Secondary | Pharmacokinetic (PK) Parameter: CL/F of EVG | CL/F is defined as the apparent oral clearance following administration of the drug. | Intensive PK Analysis set (EVG) | Posted | | Mean | Standard Deviation | mL/h | | Predose and up to 12 hours postdose on Day 10 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 12 Years | PK results were summarized for all participants age 6 to < 12 years as one group. EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg). |
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| Secondary | Pharmacokinetic (PK) Parameter: Vz/F of EVG | Vz/F is defined as the apparent volume of distribution of the drug. | Participants in the Intensive PK Analysis Set: EVG with available data were analyzed. | Posted | | Mean | Standard Deviation | mL | | Predose and up to 12 hours postdose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Age 6 to < 12 Years | PK results were summarized for all participants age 6 to < 12 years as one group. EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg). |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm | The percentage of participants achieving 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. | Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm | The percentage of participants achieving 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 with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm | The percentage of participants achieving 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 with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 400 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 with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 |
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| Secondary | Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. Week 24 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days). | Posted | | Mean | Standard Deviation | Log₁₀ copies/mL | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. Week 48 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days). | Posted | | Mean | Standard Deviation | Log₁₀ copies/ mL | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Change From Baseline in CD4 Cell Count at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days). | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Change From Baseline in CD4 Cell Count at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days). | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Change From Baseline in CD4 Percentage at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days). | Posted | | Mean | Standard Deviation | percentage (%) | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Change From Baseline in CD4 Percentage at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days). | Posted | | Mean | Standard Deviation | percentage (%) | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Tanner Stage Evaluation by Sex at Week 24 | Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). | Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. |
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| Secondary | Tanner Stage Evaluation by Sex at Week 48 | Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). | Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. |
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| Secondary | Age of First Menses | Age of first menses for female participants. | Participants in the Safety Analysis Set with available data were analyzed. Age of First Menses for participants ages 6 to < 12 years with screening HIV-1 RNA < 50 copies/mL was not analyzed because none of the participants reached their first menstruation cycle during or prior to the study. | Posted | | Mean | Standard Deviation | years | | Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL) | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL |
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| Secondary | Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group | | Palatability was only to be assessed for participants taking EVG suspension formulation. As no participants were dosed with the EVG oral suspension formulation, no data are available on its palatability. | Posted | | | | | | Up to Week 48 | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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| Secondary | Adherence to EVG | Adherence was calculated as the number of pills taken divided by number of pills prescribed multiplied by 100. | | Posted | | Mean | Standard Deviation | percentage of pills | | Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL) | | | | ID | Title | Description |
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| OG000 | Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL | EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. | | OG001 | Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL | EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) |
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