Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335192
Status:
COMPLETED
Last Update Posted:
2008-09-08
First Post:
2006-06-08
Brief Title:
To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors NRTI and of Nucleotide Analog Tenofovir Disoproxil Fumarate TDF in Patients Treated With Abacavir andor Lamivudine Given With or Without TDF
Status:
COMPLETED
Status Verified Date:
2008-09
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 evaluate if there are pharmacokinetic interactions between the NRTI 3TC and ABV and the TDF nucleotide For this purpose the intracellular and plasma levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30 days after the interruption of the TDF
Detailed Description:
There is clear evidence of pharmacokinetic interaction between ddITDF However the interaction between TDF and other NRTIs mainly at intracellular level has not been so well studied
Since all the NRTIs are anabolized at intracellular level by numerous kinases and are transported by passive carrier systems the interaction may be between TDF and other NRTIs
This study aims to investigate the pharmacokinetic interactions between the TDF and the nucleosides abacavir ABV and lamivudine 3TC at plasma and intracellular level
With this objective intracellular and plasma levels will be analysed in a group of patients that receive the combinations 3TC TDF ABVTDF and 3TCABVTDF together with lopinavirrtv or nevirapine Subsequently in a second phase of the study in the group of patients given ABV andor 3TC TDF lopinavirrtv the pharmacokinetic determinations will be repeated after a 4-week interruption of the TDF
Since all the NRTIs are anabolized at intracellular level by numerous kinases and are transported by passive carrier systems the interaction may be between TDF and other NRTIs
This study aims to investigate the pharmacokinetic interactions between the TDF and the nucleosides abacavir ABV and lamivudine 3TC at plasma and intracellular level
With this objective intracellular and plasma levels will be analysed in a group of patients that receive the combinations 3TC TDF ABVTDF and 3TCABVTDF together with lopinavirrtv or nevirapine Subsequently in a second phase of the study in the group of patients given ABV andor 3TC TDF lopinavirrtv the pharmacokinetic determinations will be repeated after a 4-week interruption of the TDF
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 |
|---|---|---|---|
| 2004-000948-25 | None | None | None |