Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059358
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2003-04-23
Brief Title:
Zidovudine Levels in HIV Infected Patients Being Treated for HCV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50000 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 HIVHCV 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AI049141-02 | NIH | None | httpsreporternihgovquickSearch5R01AI049141-02 |