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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01854775
First Posted: May 16, 2013
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
May 3, 2013
May 16, 2013
August 17, 2017
May 6, 2013
June 2018   (Final data collection date for primary outcome measure)
  • Pharmacokinetic (PK) Parameter: AUCtau for EVG (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
    AUCtau is defined as concentration of drug over a dosing interval.
  • PK Parameter: AUClast for TAF (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.
  • Incidence of Treatment-Emergent Serious Adverse Events (Part B) [ Time Frame: Up to 24 weeks ]
  • Incidence of All Treatment-Emergent Adverse Events (Part B) [ Time Frame: Up to 24 weeks ]
  • Measure plasma concentrations of EVG, TAF, COBI, FTC and TFV over sampling time to evaluate the steady state PK for EVG and TAF and confirm the dose of the E/C/F/TAF STR. [ Time Frame: Week 4 ]
    Calculation of plasma PK parameters for AUCtau for EVG and AUClast for TAF.
  • Incidence of treatment-emergent SAEs [ Time Frame: Week 24 ]
    To evaluate the incidence of treatment-emergent SAEs and all treatment-emergent adverse events inclusive of all subjects who received at least one dose of study drug.
Complete list of historical versions of study NCT01854775 on ClinicalTrials.gov Archive Site
  • Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 24 ]
  • Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 48 ]
  • Percentage of Participants with Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 24 ]
  • Percentage of Participants with Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 48 ]
  • Change from Baseline in Plasma log10 HIV-1 RNA (copies/mL) at Week 24 (Cohort 1 Part B only) [ Time Frame: Baseline; Week 24 ]
  • Change from Baseline in Plasma log10 HIV-1 RNA (copies/mL) at Week 48 (Cohort 1 Part B only) [ Time Frame: Baseline; Week 48 ]
  • Change from Baseline in CD4+ Cell Count (cells/μL) at Week 24 (Part B) [ Time Frame: Baseline; Week 24 ]
  • Change from Baseline in CD4+ Cell Count (cells/μL) at Week 48 (Part B) [ Time Frame: Baseline; Week 48 ]
  • Percentage Change from Baseline in CD4+ Cell Count (cells/μL) at Week 24 (Part B) [ Time Frame: Baseline; Week 24 ]
  • Percentage Change from Baseline in CD4+ Cell Count (cells/μL) at Week 48 (Part B) [ Time Frame: Baseline; Week 48 ]
  • PK Parameter: Ctau for EVG, FTC, TFV, and COBI (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.
  • PK Parameter: Cmax for EVG, TAF, FTC, TFV, and COBI (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
    Cmax is defined as the maximum concentration of drug.
  • PK Parameter: Apparent CL for EVG and TAF (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
    Apparent clearance (CL) is defined as the systemic clearance of the drug following oral administration.
  • PK Parameter: Apparent Vz for EVG and TAF (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
    Apparent Vz is defined as the apparent volume of distribution of the drug after oral administration.
  • PK Parameter: AUCtau for FTC, TFV, and COBI (Part A) [ Time Frame: Predose and up to 24 hours postdose ]
  • The percentage of subjects with plasma HIV 1 RNA less than 50 copies/mL [ Time Frame: Week 24 and Week 48 ]
    The percentage of subjects with plasma HIV 1 RNA less than 50 copies/mL at Week 24 and 48 as defined by the FDA snapshot analysis.
  • The percentage of subjects with plasma HIV 1 RNA less than 400 copies/mL [ Time Frame: Week 24 and Week 48 ]
    The percentage of subjects with plasma HIV 1 RNA less than 400 copies/mL at Week 24 and 48 as defined by the FDA snapshot analysis.
  • The change from baseline in plasma log10 HIV 1 RNA (copies/mL) and in CD4+ cell count (cells/μL) and percentage [ Time Frame: Week 24 and Week 48 ]
    The change from baseline in plasma log10 HIV 1 RNA (copies/mL) and in CD4+ cell count (cells/μL) and percentage at Week 24 and 48.
Not Provided
Not Provided
 
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
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

There will be 2 cohorts in this study, each consisting of Part A and Part B.

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) single tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acquired Immune Deficiency Syndrome (AIDS)
  • HIV Infections
Drug: E/C/F/TAF
E/C/F/TAF tablets contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF; as 11.2 mg of TAF fumarate)
  • Experimental: Cohort 1 (12 to < 18 years of age)
    Participants within the ages of 12 and <18 years old will receive E/C/F/TAF STR once daily with food.
    Intervention: Drug: E/C/F/TAF
  • Experimental: Cohort 2 (6 to < 12 years of age)
    Participants within the ages of 6 and <12 years old and weighing ≥ 25 kg will receive E/C/F/TAF STR once daily with food.
    Intervention: Drug: E/C/F/TAF
Gaur AH, Kizito H, Prasitsueubsai W, Rakhmanina N, Rassool M, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, Porter D, Shao Y, Myers M, Ting L, SenGupta D, Quirk E, Rhee MS. Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial. Lancet HIV. 2016 Dec;3(12):e561-e568. doi: 10.1016/S2352-3018(16)30121-7. Epub 2016 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2021
June 2018   (Final data collection date for primary outcome measure)

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 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.

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.

Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Thailand,   Uganda,   United States
Mexico
 
NCT01854775
GS-US-292-0106
2013-002780-26 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP