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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 (ASTRAL-5)

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ClinicalTrials.gov Identifier: NCT02480712
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Actual Study Start Date : July 1, 2015
Primary Completion Date : April 29, 2016
Study Completion Date : June 22, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SOF/VEL
Participants will receive SOF/VEL for 12 weeks
Drug: SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 Weeks ]
  3. HCV RNA Change From Baseline/Day 1 [ Time Frame: Baseline to Week 12 ]
  4. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure was defined as:

    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
      • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
      • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    • Virologic relapse:

      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit

  5. Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment [ Time Frame: Up to 12 Weeks ]
  6. Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 [ Time Frame: Week 12; Posttreatment Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • 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

Key Exclusion Criteria:

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • 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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480712


Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Torrance, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
Lutherville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
New York, New York, United States
The Bronx, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Virginia
Richmond, Virginia, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
More Information

Publications:
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.

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02480712     History of Changes
Other Study ID Numbers: GS-US-342-1202
First Posted: June 24, 2015    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Infection
Parasitic Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents