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Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."

NCT02196064 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 519

Last updated 2015-08-05

No results posted yet for this study

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 rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.

Conditions

  • Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Juan Antonio Pineda Vergara · Hospital Universitario Virgen de Valme

  • Antonio Rivero Román · Hospital Universitario Reina Sofía

  • Dolores Merino Muñoz · Complejo Hospitalario de Especialidades Juan Ramón Jimenez

  • María José Rios Villega · Hospital Universitario Virgen Macarena

  • Francisco Téllez Pérez · Hospital La Línea de la Concepción

  • Inés Pérez Camacho · Hospital de Poniente

  • Antonio Collado Romacho · Complejo Hospitario Torrecárdenas

  • Josefa Ruiz Morales · Hospital Universitario Virgen de la Victoria

  • Marcial Delgado Fernández · Hospital Regional de Malaga

  • Leopoldo Muñoz Medina · Hospital Universitario San Cecilio

  • Francisco Vera Méndez · Hospital Santa María de Rosell

  • Nuria Espinosa Aguilera · Hospitales Universitarios Virgen del Rocío

  • Iganacio Santos Gil · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Juan González García · Hospital Universitario La Paz

  • Antonio Vergara de Campos · Hospital Universitario de Puerto Real

  • Juan Berenguer Berenguer · Hospital Universitario Gregorio Marañón

  • Federico Pulido Ortega · Hospital 12 de Octubre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196064 on ClinicalTrials.gov