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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141284
First received: August 30, 2005
Last updated: May 9, 2011
Last verified: May 2011
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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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141284
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
| ClinicalTrials.gov Identifier: | NCT00141284 History of Changes |
| Other Study ID Numbers: | A4301003 |
| Study First Received: | August 30, 2005 |
| Last Updated: | May 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Digestive System Diseases Enterovirus Infections Flaviviridae Infections Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases |
Nelfinavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015