Influence of Nevirapine on HCV Viral Load

HCV Infection. Clinical Trial

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Official title:

Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01277627
• Other study ID #: JAP-NEV-2010-01
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2011
• Last updated: January 14, 2011
• Start date: January 2011

Study information

• Verified date: December 2010
• Source: Valme University Hospital
• Contact: JOSE MIRA-ESCARTI, M.D
• Phone: +34-955015363
• Email: miraescarti[@]yahoo.es
• Is FDA regulated: No
• Health authority: Spain: Clinical Trials Andalusian Organization, Andalusian Health System
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HCV Infection.
• HCV Viral Load.

Intervention

Drug:
• Nevirapine
nevirapine: 400 mg a day.
• efavirenz, protease inhibitors
efavirenz: 600 mg a day

Locations

Country	Name	City	State
Spain	Valme University Hospital	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Valme University Hospital	Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HCV viral load		48 weeks	No