NCT01277627

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

January 17, 2011

Status Verified

December 1, 2010

Enrollment Period

1.5 years

First QC Date

January 14, 2011

Last Update Submit

January 14, 2011

Conditions

HCV Infection.HCV Viral Load.

Keywords

HCVHIVNevirapineHCV viral loadEfavirenzProtease inhibitors

Outcome Measures

Primary Outcomes (1)

  • Changes in HCV viral load

    48 weeks

Study Arms (2)

Nevirapine

ACTIVE COMPARATOR
Drug: NevirapineDrug: efavirenz, protease inhibitors

Non-nevirapine

ACTIVE COMPARATOR
Drug: NevirapineDrug: efavirenz, protease inhibitors

Interventions

NevirapineDRUG

nevirapine: 400 mg a day.

NevirapineNon-nevirapine
efavirenz, protease inhibitorsDRUG

efavirenz: 600 mg a day

NevirapineNon-nevirapine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • HCV therapy during follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valme University Hospital

Seville, Seville, 41014, Spain

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

NevirapineefavirenzProtease Inhibitors

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

JOSE MIRA-ESCARTI, M.D

CONTACT

+34-955015363miraescarti@yahoo.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Last Updated

January 17, 2011

Record last verified: 2010-12

Locations

ES(1)