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

Phase 4

Completed

• Conditions: HIV Infection; Hepatitis C

• Registration Number: NCT00141284
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Start: 2005-10
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Disposition First Submitted: 2011-01-03
• Disposition First Submitted QC: 2011-01-03
• Disposition First Posted: 2011-01-05
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-09
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Toronto, Ontario, Canada