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

NCT02276612 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-292-15152014-002673-11
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 7

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Serious Adverse Events

  The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.

  Up to Week 48

• Incidence of Treatment-Emergent Adverse Events

  The percentage of participants experiencing any treatment-emergent adverse event was summarized.

  Up to Week 48

Secondary Outcomes (6)

• Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)

  Week 24

• Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)

  Week 48

• Change From Baseline in CD4 Cell Count at Week 24

  Baseline; Week 24

• Change From Baseline in CD4 Cell Count at Week 48

  Baseline; Week 48

• Change From Baseline in CD4 Percentage at Week 24

  Baseline; Week 24

Study Arms (1)

E/C/F/TAF

EXPERIMENTAL

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

Interventions

E/C/F/TAF DRUG

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

Also known as: Genvoya®

E/C/F/TAF

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (7)

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Soweto, South Africa

Location

MeSH Terms

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trial Disclosures & Data Transparency
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 28, 2014
• Study Start: December 3, 2014
• Primary Completion: November 10, 2016
• Study Completion: October 23, 2017
• Last Updated: November 19, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

ZA (3); US (4)