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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00141284

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infection Hepatitis C	Drug: nelfinavir 1,250 mg twice daily Drug: Zidovudine 300 mg twice daily Drug: Lamivudine 150 mg twice daily	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bakersfield	California	United States	93301
2	Pfizer Investigational Site	Miami	Florida	United States	33136
3	Pfizer Investigational Site	Shreveport	Louisiana	United States	71130
4	Pfizer Investigational Site	Dallas	Texas	United States	75390
5	Pfizer Investigational Site	Toronto	Ontario	Canada	M5G 2C4