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

Hepatitis C Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141284
• Other study ID #: A4301003
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2005
• Last updated: May 9, 2011
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infection

Intervention

Drug:
• nelfinavir 1,250 mg twice daily

• Zidovudine 300 mg twice daily

• Lamivudine 150 mg twice daily

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Toronto	Ontario
United States	Pfizer Investigational Site	Bakersfield	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.

External Links

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