Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."
NCT ID: NCT02196064
Last Updated: 2015-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
519 participants
OBSERVATIONAL
2014-05-31
2015-07-31
Brief Summary
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Detailed Description
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The main objective is 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 rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Variables collected within in the cohort:
* Demographic variable: age, sex.
* Variables related to hepatitis C virus-infection: infection route, genotype, grade of hepatic fibrosis and method used for its determination, baseline Child-Pugh index in patients with cirrhosis, previous hepatic decompensations.
* Variables related to HIV-infection: CDC clinical category, HIV viral load, CD4 cell count, previous and new antiretroviral drugs.
* Blood test: AST, ALT platelets, cholesterol, bilirubin, gamma-glutamyltransferase, alkaline phosphatase, creatinine.
* Other variables: alcohol intake, self-reported adverse events, abnormal clinical findings.
* Cause of discontinuing antiviral when applicable.
Endpoints
1. Primary endpoint: Emergence of grade 3-4 TEs/grade 4 TBEs (hepatic toxicity) from baseline to week 48.
2. Secondary endpoints
* Emergence of hepatic adverse events.
* Drug interruptions due to liver toxicity.
* Development of hepatic decompensations.
* CD4 and viral load changes from baseline to week 48.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Safety of the three-drug combination TDF/FTC/RPV
A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Juan Antonio Pineda Vergara
Role: STUDY_CHAIR
Hospital Universitario Virgen de Valme
Antonio Rivero Román
Role: STUDY_CHAIR
Hospital Universitario Reina Sofía
Dolores Merino Muñoz
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
María José Rios Villega
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Francisco Téllez Pérez
Role: PRINCIPAL_INVESTIGATOR
Hospital La Línea de la Concepción
Inés Pérez Camacho
Role: PRINCIPAL_INVESTIGATOR
Hospital de Poniente
Antonio Collado Romacho
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitario Torrecárdenas
Josefa Ruiz Morales
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen de la Victoria
Marcial Delgado Fernández
Role: PRINCIPAL_INVESTIGATOR
Hospital Regional de Malaga
Leopoldo Muñoz Medina
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario San Cecilio
Francisco Vera Méndez
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa María de Rosell
Nuria Espinosa Aguilera
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Iganacio Santos Gil
Role: PRINCIPAL_INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Juan González García
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Antonio Vergara de Campos
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Puerto Real
Juan Berenguer Berenguer
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Gregorio Marañón
Federico Pulido Ortega
Role: PRINCIPAL_INVESTIGATOR
Hospital 12 de Octubre
Locations
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Fundación Pública Andaluza Progreso y Salud
Seville, Sevilla, Spain
Countries
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Other Identifiers
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hEPAtic
Identifier Type: -
Identifier Source: org_study_id
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