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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Hepatitis C; HIV Infection

Treatments: Drug: nelfinavir 1,250 mg twice daily; Drug: Lamivudine 150 mg twice daily; Drug: Zidovudine 300 mg twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141284

A4301003

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)