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OpenTrials
Completed

NCT Number: NCT00141284

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

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

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nelfinavir 1,250 mg twice daily

Drug

Zidovudine 300 mg twice daily

Drug

Lamivudine 150 mg twice daily

Drug

Primary outcomes

  1. 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 outcomes

  1. To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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