Zidovudine Levels in HIV Infected Patients Being Treated for HCV

Phase 1

Completed

• Conditions: HIV Infections; Hepatitis C
• Interventions: Drug: Ribavirin plus interferon alfa-2b; Drug: Ribavirin; Drug: Peginterferon alfa-2b

• Registration Number: NCT00059358
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2003-04-23
• Study First Submitted QC: 2003-04-23
• Study First Posted: 2003-04-24
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ribavirin plus interferon alfa-2b	Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48
1	Ribavirin	Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48
1	Peginterferon alfa-2b	Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UPR Adult ACTU; 🇵🇷 San Juan, Puerto Rico