Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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

January 14, 2011
January 14, 2011
January 2011
July 2012   (final data collection date for primary outcome measure)
Changes in HCV viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Influence of Nevirapine on HCV Viral Load
Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • HCV Infection.
  • HCV Viral Load.
  • Drug: Nevirapine
    nevirapine: 400 mg a day.
  • Drug: efavirenz, protease inhibitors
    efavirenz: 600 mg a day
  • Active Comparator: Nevirapine
    Interventions:
    • Drug: Nevirapine
    • Drug: efavirenz, protease inhibitors
  • Active Comparator: Non-nevirapine
    Interventions:
    • Drug: Nevirapine
    • Drug: efavirenz, protease inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
Not Provided
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: JOSE MIRA-ESCARTI, M.D +34-955015363 miraescarti@yahoo.es
Spain
 
NCT01277627
JAP-NEV-2010-01
No
JOSE ANTONIO MIRA-ESCARTI, INFECTIOUS DISEASES UNIT, VALME UNIVERSITY HOSPITAL, SEVILLE, SPAIN
Valme University Hospital
Boehringer Ingelheim
Not Provided
Valme University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP