Brief Summary
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents.
The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg (Part B).
The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.
The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg (Part B).
The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.
Brief Title
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Eligibility Criteria
Key Inclusion Criteria:
* Cohort 1
* 12 years to \< 18 years of age at baseline
* Weight greater than or equal to 35 kg (77 lbs)
* Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
* Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
* No prior use of any approved or experimental anti-HIV-1 drug for any length of time
* Cohort 2
* 6 years to \< 12 years of age at baseline
* Weight greater than or equal to 25 kg (55 lbs)
* Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
* Cohort 3
* Age at baseline: ≥ 2 years old
* Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs)
* Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR
Key Exclusion Criteria:
* Hepatitis B or hepatitis C virus infection
* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
* Individuals experiencing decompensated cirrhosis
* Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
* Cohort 1
* 12 years to \< 18 years of age at baseline
* Weight greater than or equal to 35 kg (77 lbs)
* Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
* Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
* No prior use of any approved or experimental anti-HIV-1 drug for any length of time
* Cohort 2
* 6 years to \< 12 years of age at baseline
* Weight greater than or equal to 25 kg (55 lbs)
* Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
* Cohort 3
* Age at baseline: ≥ 2 years old
* Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs)
* Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR
Key Exclusion Criteria:
* Hepatitis B or hepatitis C virus infection
* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
* Individuals experiencing decompensated cirrhosis
* Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Cohort 1
* 12 years to \< 18 years of age at baseline
* Weight greater than or equal to 35 kg (77 lbs)
* Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
* Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
* No prior use of any approved or experimental anti-HIV-1 drug for any length of time
* Cohort 2
* 6 years to \< 12 years of age at baseline
* Weight greater than or equal to 25 kg (55 lbs)
* Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
* Cohort 3
* Age at baseline: ≥ 2 years old
* Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs)
* Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR
Inclusion/
* Cohort 1
* 12 years to \< 18 years of age at baseline
* Weight greater than or equal to 35 kg (77 lbs)
* Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
* Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
* No prior use of any approved or experimental anti-HIV-1 drug for any length of time
* Cohort 2
* 6 years to \< 12 years of age at baseline
* Weight greater than or equal to 25 kg (55 lbs)
* Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
* Cohort 3
* Age at baseline: ≥ 2 years old
* Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs)
* Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR
Inclusion/
Gender
All
Gender Based
false
Keywords
Adolescents
HIV-1
HIV
Treatment-naive
Virologically suppressed
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
2 Years
NCT Id
NCT01854775
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
GS-US-292-0106
Overall Status
Active, not recruiting
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Primary Outcomes
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Measure
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)
Outcome Time Frame
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
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Measure
PK Parameter: AUCtau of EVG (Cohort 2)
Outcome Time Frame
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
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Measure
PK Parameter: AUCtau of EVG (Cohort 3)
Outcome Time Frame
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
Outcome Description
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome Measure
PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)
Outcome Time Frame
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
Outcome Description
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome Measure
PK Parameter: AUClast of TAF (Cohort 2)
Outcome Time Frame
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
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Measure
PK Parameter: AUCtau of TAF (Cohort 3)
Outcome Time Frame
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
Outcome Description
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.
* 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.
Outcome Measure
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Outcome Time Frame
From first dose date up to Week 24
Outcome Description
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.
* 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.
Outcome Measure
Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
Outcome Time Frame
From first dose date up to Week 24
Outcome Description
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.
* 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.
Outcome Measure
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
Outcome Time Frame
From first dose date up to Week 24
Secondary Ids
Secondary Id
2013-002780-26
Secondary Outcomes
Outcome Description
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)
Outcome Description
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome Time Frame
(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
Outcome Measure
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)
Outcome Description
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)
Outcome Description
Cmax is defined as the maximum concentration of drug.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)
Outcome Description
Cmax is defined as the maximum concentration of drug.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)
Outcome Description
Cmax is defined as the maximum concentration of drug.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)
Outcome Description
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
Outcome Time Frame
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
Outcome Measure
PK Parameter: CL of EVG and TAF (Cohort 1)
Outcome Description
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
Outcome Time Frame
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
Outcome Measure
PK Parameter: CL of EVG and TAF (Cohort 2)
Outcome Description
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
Outcome Time Frame
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
Outcome Measure
PK Parameter: CL of EVG and TAF (Cohort 3)
Outcome Description
Vz is defined as the volume of distribution of the drug after intravenous administration.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Vz of EVG and TAF (Cohort 1)
Outcome Description
Vz is defined as the volume of distribution of the drug after intravenous administration.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Vz of EVG and TAF (Cohort 2)
Outcome Description
Vz is defined as the volume of distribution of the drug after intravenous administration.
Outcome Time Frame
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
Outcome Measure
PK Parameter: Vz of EVG and TAF (Cohort 3)
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Time Frame
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
Outcome Measure
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Time Frame
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
Outcome Measure
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)
Outcome Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome Time Frame
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
Outcome Measure
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)
Outcome Description
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.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Outcome Description
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.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 24
Outcome Measure
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Outcome Description
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Outcome Time Frame
Week 48
Outcome Measure
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48
Outcome Time Frame
Baseline, Week 24
Outcome Measure
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24
Outcome Time Frame
Baseline, Week 48
Outcome Measure
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Donna Futterman
Investigator Email
DFUTTERM@montefiore.org
Investigator Phone
718-882-0322 / 718-882-0232