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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141284
First Posted: September 1, 2005
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Enrollment: 12
Study Start Date: October 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141284


Locations
United States, California
Pfizer Investigational Site
Bakersfield, California, United States, 93301
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71130
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75390
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00141284     History of Changes
Other Study ID Numbers: A4301003
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Zidovudine
Nelfinavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites