Influence of Nevirapine on HCV Viral Load

NCT ID: NCT01277627

Last Updated: 2011-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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

Detailed Description

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Conditions

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HCV Infection. HCV Viral Load.

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Nevirapine

Group Type ACTIVE_COMPARATOR

Nevirapine

Intervention Type DRUG

nevirapine: 400 mg a day.

efavirenz, protease inhibitors

Intervention Type DRUG

efavirenz: 600 mg a day

Non-nevirapine

Group Type ACTIVE_COMPARATOR

Nevirapine

Intervention Type DRUG

nevirapine: 400 mg a day.

efavirenz, protease inhibitors

Intervention Type DRUG

efavirenz: 600 mg a day

Interventions

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Nevirapine

nevirapine: 400 mg a day.

Intervention Type DRUG

efavirenz, protease inhibitors

efavirenz: 600 mg a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Valme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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INFECTIOUS DISEASES UNIT, VALME UNIVERSITY HOSPITAL, SEVILLE, SPAIN

Locations

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Valme University Hospital

Seville, Seville, Spain

Site Status

Countries

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Spain

Central Contacts

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JOSE MIRA-ESCARTI, M.D

Role: CONTACT

+34-955015363

Facility Contacts

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JOSE A MIRA-ESCARTI, M.D

Role: primary

+34-955015363

Other Identifiers

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JAP-NEV-2010-01

Identifier Type: -

Identifier Source: org_study_id

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