Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
NCT ID: NCT02480712
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2015-07-01
2016-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SOF/VEL
Participants will receive SOF/VEL for 12 weeks
SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily
Interventions
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SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV genotype 1, 2, 3, 4, 5, 6
* Cirrhosis determination, a fibroscan or liver biopsy may be required
* HIV-1 infection
* Use of protocol specified method(s) of contraception
* Screening laboratory values within defined thresholds
Exclusion Criteria
* Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
* Screening ECG with clinically significant abnormalities
* Pregnant or nursing female or male with pregnant female partner
* Infection with hepatitis B virus (HBV)
* Use of any prohibited concomitant medications as described in the protocol
* Chronic use of systemically administered immunosuppressive agents
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Torrance, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
New York, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Richmond, Virginia, United States
Countries
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References
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Wyles D, Brau N, Kottilil S, Daar E, Workowski K, Luetkemeyer A, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Patients Co-Infected with HCV and HIV-1: The Phase 3 ASTRAL-5 Study [Abstract PS104]. 2016 European Association for the Study of the Liver (EASL), Barcelona, Spain.
Wyles D, Brau N, Kottilil S, Daar ES, Ruane P, Workowski K, Luetkemeyer A, Adeyemi O, Kim AY, Doehle B, Huang KC, Mogalian E, Osinusi A, McNally J, Brainard DM, McHutchison JG, Naggie S, Sulkowski M; ASTRAL-5 Investigators. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017 Jul 1;65(1):6-12. doi: 10.1093/cid/cix260.
Other Identifiers
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GS-US-342-1202
Identifier Type: -
Identifier Source: org_study_id
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