An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
Primary Purpose
HIV Infection, Hepatitis C
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
nelfinavir 1,250 mg twice daily
Zidovudine 300 mg twice daily
Lamivudine 150 mg twice daily
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
To Evaluate the safety of nelfinavir 1,250 mg orally taken twice daily in HIV/HCV co infected adult subjects with compensated cirrhosis (Child Pugh A) or hepatic fibrosis.
Secondary Outcome Measures
To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00141284
Brief Title
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
Official Title
A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With Lamivudine/Zidovudine (Combivir) Background Therapy In Hiv/Hepatitis C Virus (Hcv) Co-Infected Subjects With Hepatic Dysfunction.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
nelfinavir 1,250 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Zidovudine 300 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Lamivudine 150 mg twice daily
Primary Outcome Measure Information:
Title
To Evaluate the safety of nelfinavir 1,250 mg orally taken twice daily in HIV/HCV co infected adult subjects with compensated cirrhosis (Child Pugh A) or hepatic fibrosis.
Secondary Outcome Measure Information:
Title
To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4301003&StudyName=An%20Open%20Label%20Study%20To%20Evaluate%20The%20Safety%20and%20Kinetics%20of%20Nelfinavir%20in%20%20Subjects%20with%20HIV%20and%20Hepatitis%20C%20%20%20%20
Description
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Learn more about this trial
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
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