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

Pfizer logo

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)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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