Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection

Part of paid clinical trials in San Diego, California.

Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study ID
NCT04042740
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glecaprevir/Pibrentasvir (G/P) — DRUG
    Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.

Study Details

The purpose of this study was to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks for treatment of acute hepatitis C (HCV), with or without HIV-1 coinfection.

Key Dates

Start date
Nov 20, 2019
Status verified
Jul 2024
Primary completion
May 18, 2023
Completion
Aug 22, 2023

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glecaprevir/Pibrentasvir (G/P)
    Participants were assigned to receive G/P FDC tablets to be taken orally once daily for 4 weeks (Step 1). Participants who experienced HCV re-infection, suspected relapse, virologic failure, or undefined post-treatment viremia in Step 1 were offered to enter Step 2 for re-treatment. HCV re-treatment regimens may have included G/P FDC tablets orally once daily for 8-16 weeks, or alternate regimens through clinical care.

Primary Outcome Measure

Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12) [ Time Frame: Week 16 (12 weeks post study treatment) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Ucsd, Avrc Crs (701)San DiegoCalifornia92103-
University of California, San Francisco HIV/AIDS CRS (801)San FranciscoCalifornia94110-
University of Colorado Hospital CRS (6101)AuroraColorado80045-
Whitman-Walker Institute, Inc. CRS (31791)Washington D.C.District of Columbia20005-
Johns Hopkins Adult AIDS CRSBaltimoreMaryland21287-
Massachusetts General Hospital ACTG CRS (101)BostonMassachusetts02114-
Columbia Physicians and Surgeons CRS (30329)New YorkNew York10032-
Weill Cornell Chelsea CRS (7804)New YorkNew York10010-
Weill Cornell Upton CRS (7803)New YorkNew York10065-
Unc Aids Crs (3201)Chapel HillNorth Carolina27514-
University of Washington AIDS CRS (1401)SeattleWashington98104-

Find similar trials in San Diego, CA

By condition
HIV
By specialty
Infectious disease
By research site
Ucsd, Avrc Crs (701)· San Diego, CAUniversity of California, San Francisco HIV/AIDS CRS (801)· San Francisco, CAUniversity of Colorado Hospital CRS (6101)· Aurora, COWhitman-Walker Institute, Inc. CRS (31791)· Washington D.C., DCJohns Hopkins Adult AIDS CRS· Baltimore, MDMassachusetts General Hospital ACTG CRS (101)· Boston, MA

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