Influence of Nevirapine on HCV Viral Load | NCT01277627

Studies
Influence of Nevirapine on HCV Viral Load

NCT01277627

Sponsor

Valme University Hospital

Status

Unknown status

Last Update Posted

Jan 17, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

HCV Infection.
HCV Viral Load.

Interventions

Nevirapine
efavirenz, protease inhibitors

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Not provided

First Submitted Date

Jan 14, 2011

First Submission Date that Met QC Criteria

Jan 14, 2011

First Posted Date

Jan 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2011

Last Update Posted Date

Jan 17, 2011Estimated

Name	Class
Boehringer Ingelheim	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nevirapine	Active Comparator		Drug: Nevirapine Drug: efavirenz, protease inhibitors
Non-nevirapine	Active Comparator		Drug: Nevirapine Drug: efavirenz, protease inhibitors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nevirapine	Drug	nevirapine: 400 mg a day.	Nevirapine Non-nevirapine

Measure	Description	Time Frame
Changes in HCV viral load		48 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JOSE MIRA-ESCARTI, M.D	Contact	+34-955015363		miraescarti@yahoo.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Valme University Hospital		Seville	Seville	41014	Spain

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019829	Nevirapine
C098320	efavirenz
D011480	Protease Inhibitors

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004791	Enzyme Inhibitors

Browse Leaves

Not provided

Browse Branches

Not provided