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

Completed · Phase 2

Conditions studied: Hepatitis C Infection, HIV Infection

In brief

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 facts

Study ID

NCT04042740

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

45

Starts

2019-11-20

Expected to finish

2023-08-22

Last updated by the study team

2024-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute HCV infection (or reinfection) within 24 weeks prior to entry
• Detectable HCV RNA at the screening visit

You may not qualify if…

• Any HCV treatment during the current acute HCV infection episode
• Known preexisting cirrhosis
• Acute HIV-1 infection
• Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV)
• Chronic use of systemically administered immunosuppressive agents
• History of solid organ transplantation
• History of conditions that could interfere with the absorption of the study drug
• Concurrent use of prohibited medications
• Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation
• Females who are pregnant or breastfeeding
• Males with pregnant female partner

Where it is running

• Ucsd, Avrc Crs (701) — San Diego, California, United States
• University of California, San Francisco HIV/AIDS CRS (801) — San Francisco, California, United States
• University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States
• Whitman-Walker Institute, Inc. CRS (31791) — Washington D.C., District of Columbia, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS (101) — Boston, Massachusetts, United States
• Weill Cornell Chelsea CRS (7804) — New York, New York, United States
• Columbia Physicians and Surgeons CRS (30329) — New York, New York, United States
• Weill Cornell Upton CRS (7803) — New York, New York, United States
• Unc Aids Crs (3201) — Chapel Hill, North Carolina, United States
• University of Washington AIDS CRS (1401) — Seattle, Washington, United States
• Instituto de Pesquisa Clinica Evandro Chagas (12101) — Rio de Janeiro, Brazil

Full record on ClinicalTrials.gov

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