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 currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01854775
First received: May 3, 2013
Last updated: August 25, 2015
Last verified: August 2015

May 3, 2013
August 25, 2015
May 2013
November 2016   (final data collection date for primary outcome measure)
  • Plasma pharmacokinetics (PK) profiles of EVG and TAF: AUCtau and AUClast [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    This endpoint will measure the plasma PK profile of EVG and TAF. PK parameters that will be measured include AUCtau and AUClast.
  • Safety profile of E/C/F/TAF as measured by incidence of treatment-emergent serious adverse events and all treatment-emergent adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Treatment-emergent serious adverse events and adverse events will be summarized.
  • 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.
  • 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.
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 ]
  • Plasma PK profiles of EVG, TAF, FTC, TFV, and COBI: Ctau, Cmax, apparent clearance, apparent Vz, and AUCtau [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    This endpoint will measure the plasma PK profile of EVG (PK parameters: Ctau, Cmax, apparent clearance and apparent Vz); TAF (PK parameters: Cmax, apparent clearance and apparent Vz); and FTC, tenofovir (TFV), and COBI (PK parameters: AUCtau, Cmax, and Ctau).
  • 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.
 
Recruiting
74
December 2021
November 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
No
Contact: Skanda Goudar 650-524-4274 skanda.goudar@gilead.com
United States,   Mexico,   South Africa,   Thailand,   Uganda
 
NCT01854775
GS-US-292-0106, 2013-002780-26
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Devi SenGupta, MD Gilead Sciences
Gilead Sciences
August 2015

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