Have you or your loved ones been diagnosed with acquired immune deficiency syndrome (aids)?
You may be eligible to participate in a acquired immune deficiency syndrome (aids) clinical trial.
Have you or your loved ones been diagnosed with acquired immune deficiency syndrome (aids)? You may be eligible to participate in a acquired immune deficiency syndrome (aids) clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Acquired Immune Deficiency Syndrome (AIDS) Clinical Trial in Atlanta GA
Have you or your loved ones been diagnosed with acquired immune deficiency syndrome (aids)?
You may be eligible to participate in a acquired immune deficiency syndrome (aids) clinical trial.
Have you or your loved ones been diagnosed with acquired immune deficiency syndrome (aids)? You may be eligible to participate in a acquired immune deficiency syndrome (aids) clinical trial.
Active not recruiting
Male & Female
2 - 17
Years old
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.
Details for the study
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
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
Brief Summary
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for <br /> elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the <br /> elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to <br /> evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human <br /> immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive <br /> adolescents. <br /> <br /> The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically <br /> suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered <br /> E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through <br /> Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ <br /> 25 kg (Part B). <br /> <br /> The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose <br /> of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in <br /> virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 <br /> kg.
Treatments and/or Procedures
E c f TAF
Tablets administered orally with food.
E c f TAF low dose
90/90/120/6 mg STR administered once daily orally with food.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
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.
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.
Primary
PK Parameter: AUCtau of TAF (Cohort 3)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Primary
PK Parameter: AUClast of TAF (Cohort 2)
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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.
Primary
PK Parameter: AUCtau of EVG (Cohort 3)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Primary
PK Parameter: AUCtau of EVG (Cohort 2)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Primary
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)
Cmax is defined as the maximum concentration of drug.
Secondary
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)
Cmax is defined as the maximum concentration of drug.
Secondary
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)
Cmax is defined as the maximum concentration of drug.
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.
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.
Secondary
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)
Ctau is defined as the observed drug concentration at the end of the dosing interval.
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.
Secondary
PK Parameter: CL of EVG and TAF (Cohort 2)
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
Secondary
PK Parameter: CL of EVG and TAF (Cohort 1)
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
Secondary
PK Parameter: Vz of EVG and TAF (Cohort 1)
Vz is defined as the volume of distribution of the drug after intravenous administration.
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.
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.
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.
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.
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.
Secondary
PK Parameter: CL of EVG and TAF (Cohort 3)
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.
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.
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.
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.
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 verses time curve over the dosing interval).
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 verses time curve over the dosing interval).
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 verses time curve over the dosing interval).
Secondary
PK Parameter: Vz of EVG and TAF (Cohort 3)
Vz is defined as the volume of distribution of the drug after intravenous administration.
Secondary
PK Parameter: Vz of EVG and TAF (Cohort 2)
Vz is defined as the volume of distribution of the drug after intravenous administration.
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.
Study 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.