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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141284

Enrollment

Registered

2005-09-01

Start date

2005-10-31

Completion date

2006-12-31

Last updated

2011-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, HIV Infection

Brief summary

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

Interventions

DRUGnelfinavir 1,250 mg twice daily

DRUGZidovudine 300 mg twice daily

DRUGLamivudine 150 mg twice daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026