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Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

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ClinicalTrials.gov Identifier: NCT02276612
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : February 22, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.

Condition or disease Intervention/treatment Phase
HIV Drug: E/C/F/TAF Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents
Actual Study Start Date : December 3, 2014
Actual Primary Completion Date : November 10, 2016
Actual Study Completion Date : October 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: E/C/F/TAF

Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks.

After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country.

Drug: E/C/F/TAF
150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food
Other Name: Genvoya®




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Serious Adverse Events [ Time Frame: Up to Week 48 ]
    The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to Week 48 ]
    The percentage of participants experiencing any treatment-emergent adverse event was summarized.


Secondary Outcome Measures :
  1. Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) [ Time Frame: Week 24 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  2. Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) [ Time Frame: Week 48 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  3. Change From Baseline in CD4 Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  4. Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  5. Change From Baseline in CD4 Percentage at Week 24 [ Time Frame: Baseline; Week 24 ]
  6. Change From Baseline in CD4 Percentage at Week 48 [ Time Frame: Baseline; Week 48 ]


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
  • Weight ≥ 35 kg (77 lbs.)
  • Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months
  • CD4+ cell count > 100 cells/μL
  • No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • No evidence of current hepatitis B virus (HBV) infection
  • No evidence of current hepatitis C virus (HCV) infection

Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Key Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to Screening
  • Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
  • Pregnant or lactating subjects

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


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): NCT02276612


Locations
United States, Florida
Tampa, Florida, United States
United States, Michigan
Detroit, Michigan, United States
United States, New York
New York, New York, United States
United States, Tennessee
Memphis, Tennessee, United States
South Africa
Cape Town, South Africa
Johannesburg, South Africa
Soweto, South Africa
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02276612     History of Changes
Other Study ID Numbers: GS-US-292-1515
2014-002673-11 ( EudraCT Number )
First Posted: October 28, 2014    Key Record Dates
Results First Posted: February 22, 2018
Last Update Posted: November 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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