NCT00141284

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2005

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

August 30, 2005

Last Update Submit

May 9, 2011

Conditions

HIV InfectionHepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

nelfinavir 1,250 mg twice dailyDRUG
Zidovudine 300 mg twice dailyDRUG
Lamivudine 150 mg twice dailyDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV/ Hepatitic C co infected with documented HCV viremia evidence for cirrhosis and or hepatic fibrosis on liver biopsy, positive fibrosis index, stable health

You may not qualify if:

  • Decompensated cirrhosis (Child Pugh B or C)
  • Pregnant or lactating women
  • History of previous antiretrovirals \> 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Bakersfield, California, 93301, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71130, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390, United States

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 2C4, Canada

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Interventions

NelfinavirZidovudineLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesZalcitabineDeoxycytidineCytidine

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

CA(1)US(4)