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Completed

NCT Number: NCT02276612

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

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.

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Key information

Conditions

HIV

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E/C/F/TAF

Drug

150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Other names: Genvoya®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 28, 2014
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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