Status:
COMPLETED
Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."
Lead Sponsor:
Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Gilead Sciences
Conditions:
Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of r...
Detailed Description
This is a retrospective analysis of the prospective multicenter, observational "HEPAVIR HEPATIC SAFETY Cohort" (NCT01908660), in which the hepatic safety of the three-drug combination TDF/FTC/RPV will...
Eligibility Criteria
Inclusion
- ≥ 18 years old.
- Chronic HIV-1 infection, as diagnosed on the basis of the presence of serum HIV antibodies detected by EIA and western-blot.
- Chronic HCV infection as proven by detecting HCV antibodies in plasma, as well as detectable plasma HCV-RNA by PCR.
- To start a new ART regimen during the study period.
Exclusion
- Subjects with hepatotoxic events in the 2 months previous to Eviplera® treatment.
- Acute infections or uncontrolled chronic infection in the two months previous to Eviplera® treatment.
- Concomitant use of any drug with potential drug-drug interaction with Eviplera®.
- Documented resistance to study drugs.
- Concomitant therapy including anti-HCV agents, cytotoxic chemotherapy or immunosuppressors during Eviplera® treatment.
- Subjects taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks before Eviplera® treatment.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
519 Patients enrolled
Trial Details
Trial ID
NCT02196064
Start Date
May 1 2014
End Date
July 1 2015
Last Update
August 5 2015
Active Locations (1)
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1
Fundación Pública Andaluza Progreso y Salud
Seville, Sevilla, Spain, 41092