Clinical Trials

MainTitle

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
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT01854775

First received: May 3, 2013
Last updated: August 15, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections

Drug : E/C/F/TAF
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • 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 ]
Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 6, 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
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 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.
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)

Eligibility

Eligibility

Ages Eligible for Study: 6 Years to 17 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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 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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854775

Locations

United States, California
Miller's Children Hospital
Long Beach, California, United States, 90806
United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20852
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
South Africa
Desmond Tutu HIV Foundation
Cape Town, South Africa, 7925
Clinical HIV Research Unit
Johannesburg, South Africa, 2092
Thailand
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
Pathumwan, Bangkok, Thailand, 10330
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Muang, Khon Kaen, Thailand, 40002
Queen Savang Vadhana Memorial Hospital
Chonburi, Thailand, 20110
Uganda
Joint Clinical Research Centre
Lubowa Hill, Kampala, Uganda, PO Box 10005

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT01854775   History of Changes  
Other Study ID Numbers: GS-US-292-0106  
  2013-002780-26  
Study First Received: May 3, 2013  
Last Updated: August 15, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Gilead Sciences:

Adolescents
HIV-1
HIV
Treatment-naive

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Tenofovir
Antiviral Agents
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.