NCT02480712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 1, 2017

Completed
Last Updated

November 16, 2018

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

June 22, 2015

Results QC Date

April 26, 2017

Last Update Submit

October 19, 2018

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

    Posttreatment Week 12

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

    Up to 12 weeks

Secondary Outcomes (6)

  • Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Posttreatment Weeks 4 and 24

  • Percentage of Participants With HCV RNA < LLOQ on Treatment

    Up to 12 Weeks

  • 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 That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment

    Up to 12 Weeks

  • +1 more secondary outcomes

Study Arms (1)

SOF/VEL

EXPERIMENTAL

Participants will receive SOF/VEL for 12 weeks

Drug: SOF/VEL

Interventions

SOF/VELDRUG

400/100 mg fixed-dose combination (FDC) tablet administered orally once daily

Also known as: GS-7977/GS-5816, Epclusa®
SOF/VEL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Lutherville, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Related Publications (2)

  • 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.

    RESULT

  • 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.

    PMID: 28369210DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Clinical Trial Disclosures
Organization
Gilead Sciences
ClinicalTrialDisclosures@gilead.com

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 24, 2015

Study Start

July 1, 2015

Primary Completion

April 29, 2016

Study Completion

June 22, 2016

Last Updated

November 16, 2018

Results First Posted

June 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

US(15)