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| 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: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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: | Jose F. Rodriguez, PhD, MSC-UPR |
| ClinicalTrials.gov Identifier: | NCT00059358 History of Changes |
| Other Study ID Numbers: | 1R01AI09141-01A1, 5R01AI049141-02 |
| Study First Received: | April 23, 2003 |
| Last Updated: | August 6, 2009 |
| Health Authority: | United States: Federal Government |
|
HIV HCV Ribavirin |
Interferon Co-infection Treatment experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Ribavirin Zidovudine Peginterferon alfa-2b Antiviral Agents Anti-Infective Agents Therapeutic Uses |