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Influence of Nevirapine on HCV Viral Load (HELICON)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Valme University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Valme University Hospital
ClinicalTrials.gov Identifier:
NCT01277627
First received: January 14, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals.


Condition Intervention
HCV Infection.
HCV Viral Load.
 Drug: Nevirapine
Drug: efavirenz, protease inhibitors

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Valme University Hospital:

Primary Outcome Measures:
  • Changes in HCV viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nevirapine Drug: Nevirapine
nevirapine: 400 mg a day.
Drug: efavirenz, protease inhibitors
efavirenz: 600 mg a day
Active Comparator: Non-nevirapine Drug: Nevirapine
nevirapine: 400 mg a day.
Drug: efavirenz, protease inhibitors
efavirenz: 600 mg a day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection.
  • Older than 18 years.
  • Chronic hepatitis C.
  • Undetectable HIV viral load during one year before starting study.
  • To have not received HCV therapy during one year before starting study.
  • To have not started efavirenz or protease inhibitors o nucleoside analogs during 6 months before starting study.
  • Non contraindications for drugs included in this study.
  • To change an antiretroviral regimen including efavirenz or protease inhibitors by nevirapine due to side effects, interactions or pregnancy (NVP group)
  • To continue with a antiretroviral regimen including efavirenz or protease inhibitors (non-NVP group)

Both groups will be matched according to these variables:

  • Liver stiffness.
  • HCV genotype.
  • Hospital.
  • Time from starting antiretroviral therapy.
  • Previous third drug (EFV or PI) to introduction of NVP.

Exclusion Criteria:

  • HCV therapy during follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277627

Contacts
Contact: JOSE MIRA-ESCARTI, M.D +34-955015363 miraescarti@yahoo.es

Locations
Spain
Valme University Hospital Not yet recruiting
Seville, Spain, 41014
Contact: JOSE A MIRA-ESCARTI, M.D     +34-955015363     miraescarti@yahoo.es    
Principal Investigator: JOSE A MIRA-ESCARTI, M.D            
Sponsors and Collaborators
Valme University Hospital
Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: JOSE ANTONIO MIRA-ESCARTI, INFECTIOUS DISEASES UNIT, VALME UNIVERSITY HOSPITAL, SEVILLE, SPAIN
ClinicalTrials.gov Identifier: NCT01277627     History of Changes
Other Study ID Numbers: JAP-NEV-2010-01
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Spain: Clinical Trials Andalusian Organization, Andalusian Health System

Keywords provided by Valme University Hospital:
HCV
HIV
Nevirapine
 HCV viral load
Efavirenz
Protease inhibitors

Additional relevant MeSH terms:
Protease Inhibitors
Nevirapine
Efavirenz
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013