Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 24, 2014
First Posted Date  ICMJE October 28, 2014
Results First Submitted Date  ICMJE January 25, 2018
Results First Posted Date  ICMJE February 22, 2018
Last Update Posted Date November 19, 2018
Actual Study Start Date  ICMJE December 3, 2014
Actual Primary Completion Date November 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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.
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to Week 48 ]
    The percentage of participants experiencing any treatment-emergent adverse event was summarized.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 96 weeks plus 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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.
  • 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.
  • Change From Baseline in CD4 Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in CD4 Percentage at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4 Percentage at Week 48 [ Time Frame: Baseline; Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL (FDA snapshot analysis) [ Time Frame: Weeks 24, 48, and 96 ]
  • Change from baseline in CD4 cell count and CD4 percentage [ Time Frame: Baseline; Weeks 24, 48, and 96 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE Drug: E/C/F/TAF
150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food
Other Name: Genvoya®
Study Arms  ICMJE 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.

Intervention: Drug: E/C/F/TAF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2015)
60
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2014)
50
Actual Study Completion Date  ICMJE October 23, 2017
Actual Primary Completion Date November 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276612
Other Study ID Numbers  ICMJE GS-US-292-1515
2014-002673-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2018

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