Influence of Nevirapine on HCV Viral Load (HELICON)

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.

Study Overview

• Status: Unknown
• Conditions: HCV Infection.; HCV Viral Load.
• Intervention / Treatment: Drug: Nevirapine; Drug: efavirenz, protease inhibitors

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41014
    • Valme University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in HCV viral load	48 weeks

Collaborators and Investigators

• Sponsor: Valme University Hospital
• Collaborators: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 17, 2011
• Last Update Submitted That Met QC Criteria: January 14, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Nevirapine; HIV; HCV; Efavirenz; HCV viral load; Protease inhibitors
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Viral Protease Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Nevirapine; Protease Inhibitors; Efavirenz; HIV Protease Inhibitors
• Other Study ID Numbers: JAP-NEV-2010-01