Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021632
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2001-07-26
Brief Title:
Effects of Ribavirin on Zidovudine or Stavudine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacokinetic Evaluation of the Effects of Ribavirin RBV on Zidovudine ZDV or Stavudine d4T Triphosphate TP Formation
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The purpose of this study is to see how treatment of hepatitis C HCV patients with ribavirin RBV affects the anti-HIV drugs stavudine d4T or zidovudine ZDV
Studies have shown that RBV may interfere with the action of ZDV and d4T There is little information about the way these drugs interact in the body This study will examine how the drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV therapy
Studies have shown that RBV may interfere with the action of ZDV and d4T There is little information about the way these drugs interact in the body This study will examine how the drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV therapy
Detailed Description:
RBV a nucleoside analogue is used for the treatment of hepatitis C virus HCV in alliance with interferon-alfa 2a2b in patients with HIV-1 The mechanism of action of RBV has led to in vitro studies examining the agonismantagonism in efficacy occurring when used in combination with nucleoside reverse transcriptase inhibitors NRTIs The primary objective of the pharmacology component of this current study will be the evaluation of the effect of RBV on the intracellular activation of ZDV or d4T owing to the reported antagonism observed in vitro
Pharmacokinetic PK evaluations for plasma ZDV or d4T and intracellular ZDV or d4T and measurements of their triphosphate anabolites are performed before initial RBV dosing within 2 weeks of visit and 8 weeks after RBV administration Thymidine triphosphate TTP concentrations also are quantitated to permit estimation of the ratio of active drug to endogenous triphosphate concentrations
For entry prior to RBV dosing blood samples are collected within 2 hours prior to the ZDV or d4T dose and then at Hours 1 4 and 8 post dosing Following the entry PK blood draws patients initiate RBV treatment within 2 weeks of the first PK study day
For the Week 8 evaluation measured as 8 weeks following initiation of RBV blood samples are collected prior to the ZDV or d4T dose and then at Hours 1 4 and 8 post dosing
Pharmacokinetic PK evaluations for plasma ZDV or d4T and intracellular ZDV or d4T and measurements of their triphosphate anabolites are performed before initial RBV dosing within 2 weeks of visit and 8 weeks after RBV administration Thymidine triphosphate TTP concentrations also are quantitated to permit estimation of the ratio of active drug to endogenous triphosphate concentrations
For entry prior to RBV dosing blood samples are collected within 2 hours prior to the ZDV or d4T dose and then at Hours 1 4 and 8 post dosing Following the entry PK blood draws patients initiate RBV treatment within 2 weeks of the first PK study day
For the Week 8 evaluation measured as 8 weeks following initiation of RBV blood samples are collected prior to the ZDV or d4T dose and then at Hours 1 4 and 8 post dosing
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 |
|---|---|---|---|
| 10919 | REGISTRY | DAIDS-ES | None |
| AACTG A5092s | None | None | None |
| ACTG A5092s | None | None | None |