Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338390
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2006-06-15
Brief Title:
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDITDF With ABC3TC
Sponsor:
Hospital de Granollers
Organization:
Hospital de Granollers
Study Overview
Official Title:
Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI Tenofovir With Abacavir Lamivudine in a Single Tablet
Status:
COMPLETED
Status Verified Date:
2008-10
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 study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir lamivudine joint formulation in a single daily dose to achieve these objectives
Detailed Description:
Different works have shown a high rate of virological failure among patients on abacavir lamivudine tenofovir or ddI 3TC tenofovir thus rendering the use of these combinations actively unadvisable
Furthermore recent studies have also shown that ABC3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT3TC This provides us with grounds to suppose that patients with TDFddI may recover their CD4 with ABC3HT Similarly and recently the existence of pharmacokinetic interactions between tenofovir abacavir has begun to be questioned
Finally the replacement of tenofovir with abacavir or tenofovir ddI with abacavir lamivudine does not detract from the potency of HAART the toxicity profile is different and their behaviour at mitochondrial level is similar
This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir lamivudine joint formulation in a single daily dose to achieve these objectives
Furthermore recent studies have also shown that ABC3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT3TC This provides us with grounds to suppose that patients with TDFddI may recover their CD4 with ABC3HT Similarly and recently the existence of pharmacokinetic interactions between tenofovir abacavir has begun to be questioned
Finally the replacement of tenofovir with abacavir or tenofovir ddI with abacavir lamivudine does not detract from the potency of HAART the toxicity profile is different and their behaviour at mitochondrial level is similar
This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir lamivudine joint formulation in a single daily dose to achieve these objectives
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 |
|---|---|---|---|
| 2004-003749-42 | None | None | None |