An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
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ClinicalTrials.gov Identifier: NCT00141284 |
Recruitment Status
:
Completed
First Posted
: September 1, 2005
Last Update Posted
: May 16, 2011
|
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 12 participants |
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. |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |
- 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.
- To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
ClinicalTrials.gov Identifier: | NCT00141284 History of Changes |
Other Study ID Numbers: |
A4301003 |
First Posted: | September 1, 2005 Key Record Dates |
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 |