Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
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ClinicalTrials.gov Identifier: NCT02071082 |
Recruitment Status :
Completed
First Posted : February 25, 2014
Results First Posted : April 4, 2016
Last Update Posted : November 16, 2018
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | February 21, 2014 | ||||||||||||||
First Posted Date ICMJE | February 25, 2014 | ||||||||||||||
Results First Submitted Date ICMJE | January 21, 2016 | ||||||||||||||
Results First Posted Date ICMJE | April 4, 2016 | ||||||||||||||
Last Update Posted Date | November 16, 2018 | ||||||||||||||
Actual Study Start Date ICMJE | February 25, 2014 | ||||||||||||||
Actual Primary Completion Date | January 23, 2015 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults | ||||||||||||||
Official Title ICMJE | A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults | ||||||||||||||
Brief Summary | This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts:
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Detailed Description | Not Provided | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Other Name: Genvoya®
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
79 | ||||||||||||||
Original Estimated Enrollment ICMJE |
100 | ||||||||||||||
Actual Study Completion Date ICMJE | October 26, 2016 | ||||||||||||||
Actual Primary Completion Date | January 23, 2015 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Canada, Japan, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT02071082 | ||||||||||||||
Other Study ID Numbers ICMJE | GS-US-292-1249 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Gilead Sciences | ||||||||||||||
Study Sponsor ICMJE | Gilead Sciences | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Gilead Sciences | ||||||||||||||
Verification Date | October 2017 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |