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

Pfizer12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection Hepatitis C

Interventions

nelfinavir 1,250 mg twice dailyDRUG

Zidovudine 300 mg twice dailyDRUG

Lamivudine 150 mg twice dailyDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (5)

Pfizer Investigational Site

Bakersfield, California, United States

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

Shreveport, Louisiana, United States

Pfizer Investigational Site

Dallas, Texas, United States

Outcomes

Primary Outcomes

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 Outcomes

To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.

Data from ClinicalTrials.gov

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