NCT00059358

Brief Summary

This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients who are also being treated for hepatitis C virus (HCV) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

3.8 years

First QC Date

April 23, 2003

Last Update Submit

August 6, 2009

Conditions

HIV InfectionsHepatitis C

Keywords

HIVHCVRibavirinInterferonCo-infectionTreatment experienced

Outcome Measures

Primary Outcomes (4)

  • Steady state area under the concentration time curve (AUC) between 0 and 12 hours of zidovudine (ZDV)-MP, ZDV-TP, and dTTP in PBMCs from HIV and hepatitis C virus (HCV) coinfected patients before and after peginterferon alfa-2b with or without ribavirin

    Throughout study

  • Systemic exposure (AUC over 0 to 12 hours) of nelfinavir before and after peginterferon alfa-2b with or without ribavirin in HIV and HCV coinfected patients

    Throughout study

  • Effect of peginterferon alfa-2b with or without ribavirin in HCV RNA viral titers, alanine aminotransferase (ALT) levels, CD4+, and HIV-RNA viral titers in HIV and HCV coinfected patients

    Through Week 48

  • Effect of peginterferon alfa-2b with or without ribavirin on liver histology

    At Week 72

Study Arms (1)

1

EXPERIMENTAL

Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48

Drug: Ribavirin plus interferon alfa-2bDrug: RibavirinDrug: Peginterferon alfa-2b

Interventions

Ribavirin plus interferon alfa-2bDRUG

Oral tablets taken daily

1
RibavirinDRUG

Oral tablet taken daily

1
Peginterferon alfa-2bDRUG

Subcutaneous injection

1

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HCV-infected
  • HIV-1 infection
  • CD4 cell count \> 200 cells/mm³ within 30 days prior to study entry
  • HIV RNA \< 400 copies/ml within 90 days of study entry
  • Use of zidovudine, lamivudine, and any PI and/or NNRTI
  • ANC value \>= 1,500 ml³ within 30 days of study entry
  • Weight \> 50 kg (110 lbs) for women and \> 60 kg (132 lbs) for men
  • Acceptable methods of contraception
  • Ability and willingness to complete the Baseline Adherence Questionnaire
  • Documentation of adherence confirmed by the Baseline Adherence Questionnaire and certified by the study officials

You may not qualify if:

  • Previous ribavirin therapy
  • More than 2 months of interferon therapy
  • Current use of any NRTI other than ZDV and 3TC
  • Hepatitis B surface antigen positive
  • Infectious, autoimmune, tumoral, biliary, or vascular liver disease
  • Alcohol consumption of more than 50 g/day
  • Current use of intravenous drugs
  • Hemoglobin levels \< 10 gm/dl
  • Methadone use
  • Chemotherapy
  • Certain medications
  • Acute opportunistic or bacterial infection requiring therapy at the time of enrollment
  • Hemoglobinopathy (e.g., thalassemia) or any other cause of tendency to hemolysis
  • Psychiatric disorders, severe depression, history of suicide attempts, or suicidal ideation
  • Renal disease requiring dialysis
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPR Adult ACTU

San Juan, 00936-5067, Puerto Rico

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis CCoinfection

Interventions

RibavirinInterferon alpha-2peginterferon alfa-2b

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)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jose F. Rodriguez, PhD

    MSC-UPR

    PRINCIPAL INVESTIGATOR

  • Jorge L. Santana, MD

    MSC-UPR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

April 23, 2003

First Posted

April 24, 2003

Study Start

September 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

PR(1)