Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

The study will be conducted in two steps. In Step 1, participants will receive four weeks of treatment with G/P for acute HCV infection and then followed 24 weeks post treatment. Participants with HCV recurrence (reinfection, suspected relapse or undefined post-treatment viremia) or HCV virologic failure before or at the Step 1 Week 16/SVR12 (sustained virologic response 12 weeks post-treatment) visit may enter Step 2 for re-treatment. The remaining participants complete the study at Week 28 of Step 1. The study primary and secondary outcome measures pertain to Step 1. In Step 2, participants will be re-treated with G/P with or without ribavirin (RBV) for up to 16 weeks, and followed for 24 weeks post treatment. Post-treatment follow-up for Step 2 will include visits for SVR12 determination after re-treatment. In Step 1, study visits are scheduled at study entry, weeks 1 and 2 (on-treatment), week 4 (treatment discontinuation), and weeks 8, 12, 16 and 28 (post-treatment follow-up). In Step 2, participants will have study visits during the re-treatment period, where the number of visits depends on the re-treatment, and visits at 12 and 24 weeks post treatment. Study visits may include physical examinations, clinical assessments, blood and urine collection, questionnaires, and HCV re-infection prevention counseling.

Keywords

Hepatitis C Infection HIV Infection Acute Hepatitis C Infection Glecaprevir Pibrentasvir 4 weeks Direct-acting antivirals Infection Communicable Diseases Hepatitis A Hepatitis C Virus Diseases Hepatitis Ribavirin Glecaprevir/Pibrentasvir (G/P) Ribavirin (RBV)

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join 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.

Locations

  • Ucsd, Avrc Crs (701)
    San Diego California 92103 United States
  • Unc Aids Crs (3201)
    Chapel Hill North Carolina 27514 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Clinical Trials Group
ID
NCT04042740
Phase
Phase 2
Study Type
Interventional
Last Updated