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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

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ClinicalTrials.gov Identifier: NCT01854775
Recruitment Status : Active, not recruiting
First Posted : May 16, 2013
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Acquired Immune Deficiency Syndrome (AIDS) HIV Infections Drug: E/C/F/TAF Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Actual Study Start Date : May 6, 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Incidence of Treatment-Emergent Serious Adverse Events (Part B) [ Time Frame: Up to 24 weeks ]
  4. Incidence of All Treatment-Emergent Adverse Events (Part B) [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 24 ]
  2. Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 48 ]
  3. Percentage of Participants with Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 24 ]
  4. Percentage of Participants with Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis (Part B) [ Time Frame: Week 48 ]
  5. Change from Baseline in Plasma log10 HIV-1 RNA (copies/mL) at Week 24 (Cohort 1 Part B only) [ Time Frame: Baseline; Week 24 ]
  6. Change from Baseline in Plasma log10 HIV-1 RNA (copies/mL) at Week 48 (Cohort 1 Part B only) [ Time Frame: Baseline; Week 48 ]
  7. Change from Baseline in CD4+ Cell Count (cells/μL) at Week 24 (Part B) [ Time Frame: Baseline; Week 24 ]
  8. Change from Baseline in CD4+ Cell Count (cells/μL) at Week 48 (Part B) [ Time Frame: Baseline; Week 48 ]
  9. Percentage Change from Baseline in CD4+ Cell Count (cells/μL) at Week 24 (Part B) [ Time Frame: Baseline; Week 24 ]
  10. Percentage Change from Baseline in CD4+ Cell Count (cells/μL) at Week 48 (Part B) [ Time Frame: Baseline; Week 48 ]
  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. PK Parameter: AUCtau for FTC, TFV, and COBI (Part A) [ Time Frame: Predose and up to 24 hours postdose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01854775     History of Changes
Other Study ID Numbers: GS-US-292-0106
2013-002780-26 ( EudraCT Number )
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Tenofovir
Antiviral Agents
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors