Influence of Nevirapine on HCV Viral Load (HELICON)

Valme University Hospital

Status: Unknown

Conditions: HCV Infection.; HCV Viral Load.

Treatments: Drug: efavirenz, protease inhibitors; Drug: Nevirapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01277627

JAP-NEV-2010-01

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Nevirapine

Active Comparator group

Treatment:

Drug: efavirenz, protease inhibitors

Drug: Nevirapine

Non-nevirapine

Active Comparator group

Treatment:

Drug: efavirenz, protease inhibitors

Drug: Nevirapine