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Clinical Trials/NCT02480712
NCT02480712CompletedPhase 3

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

Gilead Sciences0 sites107 target enrollmentStarted: July 1, 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
107
Primary Endpoint
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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.

Arms & Interventions

SOF/VEL

Experimental

Participants will receive SOF/VEL for 12 weeks

Intervention: SOF/VEL (Drug)

Outcomes

Primary Outcomes

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.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time Frame: Up to 12 weeks

Secondary Outcomes

  • Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment(Up to 12 Weeks)
  • Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12(Week 12; Posttreatment Week 12)
  • Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
  • HCV RNA Change From Baseline/Day 1(Baseline to Week 12)
  • Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
  • Percentage of Participants With HCV RNA < LLOQ on Treatment(Up to 12 Weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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