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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02276612
First received: October 24, 2014
Last updated: December 6, 2016
Last verified: December 2016
  Purpose
This study will assess the safety, efficacy 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 Intervention Phase
HIV
Drug: E/C/F/TAF
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of treatment-emergent serious adverse events [ Time Frame: Up to 48 weeks plus 30 days ]
  • Incidence of treatment-emergent adverse events [ Time Frame: Up to 48 weeks plus 30 days ]

Secondary Outcome Measures:
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL (FDA defined snapshot analysis) [ Time Frame: Week 24 ]
  • Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL (FDA defined snapshot analysis) [ Time Frame: Week 48 ]
  • Change from baseline in CD4 cell count [ Time Frame: Baseline; Week 24 ]
  • Change from baseline in CD4 cell count [ Time Frame: Baseline; Week 48 ]
  • Change from baseline in CD4 percentage [ Time Frame: Baseline; Week 24 ]
  • Change from baseline in CD4 percentage [ Time Frame: Baseline; Week 48 ]

Enrollment: 60
Study Start Date: December 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV treatment-experienced
Participants will receive open-label E/C/F/TAF for up to 48 weeks followed by an optional open-label extension phase.
Drug: E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily with food
Other Name: Genvoya®

  Eligibility

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)

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
  • Hepatitis B or Hepatitis C virus infection

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

  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: 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
Observatory, Cape Town, Western Cape, 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
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02276612     History of Changes
Other Study ID Numbers: GS-US-292-1515
2014-002673-11 ( EudraCT Number )
Study First Received: October 24, 2014
Last Updated: December 6, 2016

ClinicalTrials.gov processed this record on March 22, 2017