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Zidovudine Levels in HIV Infected Patients Being Treated for HCV

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00059358
First received: April 23, 2003
Last updated: August 6, 2009
Last verified: August 2009

April 23, 2003
August 6, 2009
September 2001
June 2005   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Through Week 48 ] [ Designated as safety issue: No ]
  • Effect of peginterferon alfa-2b with or without ribavirin on liver histology [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00059358 on ClinicalTrials.gov Archive Site
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Zidovudine Levels in HIV Infected Patients Being Treated for HCV
Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin

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.

An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin.

Participants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C
  • Drug: Ribavirin plus interferon alfa-2b
    Oral tablets taken daily
  • Drug: Ribavirin
    Oral tablet taken daily
  • Drug: Peginterferon alfa-2b
    Subcutaneous injection
Experimental: 1
Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48
Interventions:
  • Drug: Ribavirin plus interferon alfa-2b
  • Drug: Ribavirin
  • Drug: Peginterferon alfa-2b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Significant coronary diseases or two or more risk factors for coronary diseases, such as > 55 years old, hypertension, and cholesterol > 250 mg/dl
  • Any clinically significant diseases (other than HIV and HCV infection) that, in the opinion of study officials, would compromise the outcome of this study
  • Pregnancy
  • Participation in blinded clinical trial
Both
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT00059358
1R01AI09141-01A1, 5R01AI049141-02
Not Provided
Jose F. Rodriguez, PhD, MSC-UPR
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Jose F. Rodriguez, PhD MSC-UPR
Principal Investigator: Jorge L. Santana, MD MSC-UPR
National Institute of Allergy and Infectious Diseases (NIAID)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP