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:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01854775
First received: May 3, 2013
Last updated: April 29, 2016
Last verified: April 2016

May 3, 2013
April 29, 2016
May 2013
April 2016   (final data collection date for primary outcome measure)
  • Pharmacokinetic (PK) Parameter: AUCtau for EVG [ Time Frame: predose, 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours postdose ] [ Designated as safety issue: No ]
    AUCtau is defined as concentration of drug over a dosing interval.
  • PK Parameter: AUClast for EVG and TAF [ Time Frame: predose, 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours postdose ] [ Designated as safety issue: No ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.
  • Incidence of treatment-emergent serious adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of all treatment-emergent adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Calculation of plasma PK parameters for AUCtau for EVG and AUClast for TAF.
  • Incidence of treatment-emergent SAEs [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of participants with plasma HIV-1 RNA < 400 copies/mL [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change from baseline in plasma log10 HIV-1 RNA (copies/mL) [ Time Frame: Baseline; Week 24; Week 48 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count (cells/μL) and percentage [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • PK Parameter: Ctau of EVG and COBI [ Time Frame: predose, 1, 2, 3, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.
  • PK Parameter: Ctau of FTC [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: Ctau of TFV [ Time Frame: predose, 1, 2, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: Cmax of EVG and COBI [ Time Frame: predose, 1, 2, 3, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
    Cmax is defined as the maximum concentration of drug.
  • PK Parameter: Cmax of FTC [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: Cmax of TAF [ Time Frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: Cmax of TFV [ Time Frame: predose, 1, 2, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: Apparent CL of EVG [ Time Frame: predose, 1, 2, 3, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
    Apparent clearance (CL) is defined as the systemic clearance of the drug following oral administration.
  • PK Parameter: Apparent CL of TAF [ Time Frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: Apparent Vz of EVG [ Time Frame: predose, 1, 2, 3, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
    Apparent Vz is defined as the apparent volume of distribution of the drug after oral administration.
  • PK Parameter: Apparent Vz of TAF [ Time Frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: AUCtau for FTC [ Time Frame: predose, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: AUCtau for TFV [ Time Frame: predose, 1, 2, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
  • PK Parameter: AUCtau for COBI [ Time Frame: predose, 1, 2, 3, 4, 5, 8, and 24 hours postdose ] [ Designated as safety issue: No ]
  • The percentage of subjects with plasma HIV 1 RNA less than 50 copies/mL [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
This study is to confirm the dose of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment naive adolescents and evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of E/C/F/TAF STR in HIV-1 infected, ARV treatment naive adolescents and virologically suppressed HIV-1 infected children. Antiviral activity will be determined by the achievement of HIV-1 RNA < 50 copies/mL at Weeks 24 and 48.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
73
December 2021
April 2016   (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 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.

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
Both
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   South Africa,   Thailand,   Uganda
Mexico
 
NCT01854775
GS-US-292-0106, 2013-002780-26
Yes
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Devi SenGupta, MD Gilead Sciences
Gilead Sciences
April 2016

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