HIV Infection Clinical Trial
— PURGE-COfficial title:
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
Verified date | March 2024 |
Source | AIDS Clinical Trials Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 22, 2023 |
Est. primary completion date | May 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - Acute HCV infection (or reinfection) within 24 weeks prior to entry. - Detectable HCV RNA at the screening visit. Exclusion Criteria - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Pesquisa Clinica Evandro Chagas (12101) | Rio de Janeiro | |
United States | University of Colorado Hospital CRS (6101) | Aurora | Colorado |
United States | Johns Hopkins Adult AIDS CRS | Baltimore | Maryland |
United States | Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts |
United States | Unc Aids Crs (3201) | Chapel Hill | North Carolina |
United States | Columbia Physicians and Surgeons CRS (30329) | New York | New York |
United States | Weill Cornell Chelsea CRS (7804) | New York | New York |
United States | Weill Cornell Upton CRS (7803) | New York | New York |
United States | 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 Washington AIDS CRS (1401) | Seattle | Washington |
United States | Whitman-Walker Institute, Inc. CRS (31791) | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
AIDS Clinical Trials Group | AbbVie, National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with sustained virologic response at 12 weeks post-treatment (SVR12) | SVR12 defined as achieving unquantifiable HCV RNA (less than the lower limit of quantification [LLOQ] target detected [TD] or target not detected [TND]) at study visit 12 weeks post treatment. If a participant does not have any HCV RNA measurements in this time period then the participant will be considered as SVR12 failure, unless there are preceding and subsequent HCV RNA measurements that are both LLOQ (either TD or TND). | Week 16 (12 weeks post treatment) | |
Primary | Proportion of participants who experienced adverse events (AEs) | Study protocol required reporting of (1) AEs Grade greater than or equal to 2, (2) AEs that led to a change in study treatment regardless of grade and (3) AEs meeting ICH definition of SAE or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) are used. | From study treatment initiation to 4 weeks after study treatment discontinuation (Week 8) | |
Primary | Number of participants who complete 4 weeks of treatment without discontinuation due to AEs | Number of participants who complete 4 weeks of treatment without discontinuation due to AEs | From study entry to Week 4 | |
Secondary | Proportion of participants with HCV RNA less than LLOQ | Proportion of participants with HCV RNA less than LLOQ (TD or TND) | Weeks 1, 2, 4, 8, 12, 28 | |
Secondary | Number of participants with HCV virologic failure | Virologic failure defined as failure to achieve unquantifiable HCV RNA and confirmed increase in HCV RNA greater than 1 log10 from on-treatment nadir | Weeks 1, 2, 4 |
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