|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00059358 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Hepatitis C |
Drug: Ribavirin plus interferon alfa-2b Drug: Ribavirin Drug: Peginterferon alfa-2b |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin |
| Estimated Enrollment: | 16 |
| Study Start Date: | September 2001 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48
|
Drug: Ribavirin plus interferon alfa-2b
Oral tablets taken daily
Drug: Ribavirin
Oral tablet taken daily
Drug: Peginterferon alfa-2b
Subcutaneous injection
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
More Information
| Responsible Party: | MSC-UPR ( Jose F. Rodriguez, PhD ) |
| Study ID Numbers: | 1R01AI09141-01A1, 5R01AI049141-02 |
| Study First Received: | April 23, 2003 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00059358 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV HCV Ribavirin |
Interferon Co-infection Treatment experienced |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Liver Diseases Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Flaviviridae Infections Antineoplastic Agents Physiological Effects of Drugs Ribavirin Hepatitis, Viral, Human Zidovudine Infection |
Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Hepatitis C Retroviridae Infections Nucleic Acid Synthesis Inhibitors Interferon-alpha RNA Virus Infections Anti-HIV Agents Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Interferons |