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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
August 30, 2005
September 1, 2005
May 16, 2011
October 2005
December 2006   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00141284 on ClinicalTrials.gov Archive Site
To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.
To evaluate the pharmacokinetics of nelfinavir and M8 , the major metabolite, in HIV/HCV co infected subjects with compensated cirrhosis or hepatic fibrosis
Not Provided
Not Provided
 
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
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.
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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infection
  • Hepatitis C
  • Drug: nelfinavir 1,250 mg twice daily
  • Drug: Zidovudine 300 mg twice daily
  • Drug: Lamivudine 150 mg twice daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2006
December 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00141284
A4301003
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP