An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C

NCT ID: NCT00141284

Last Updated: 2011-05-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to confirm the safety, efficacy and delineate the pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child Pugh A compensated cirrhosis and or Hepatic fibrosis

Detailed Description

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Conditions

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HIV Infection Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nelfinavir 1,250 mg twice daily

Intervention Type DRUG

Zidovudine 300 mg twice daily

Intervention Type DRUG

Lamivudine 150 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV/ Hepatitic C co infected with documented HCV viremia evidence for cirrhosis and or hepatic fibrosis on liver biopsy, positive fibrosis index, stable health

Exclusion Criteria

* Decompensated cirrhosis (Child Pugh B or C)
* Pregnant or lactating women
* History of previous antiretrovirals \> 14 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bakersfield, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

Other Identifiers

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A4301003

Identifier Type: -

Identifier Source: org_study_id

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