Ignite Creation Date:
2024-05-05 @ 9:01 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00795444
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2008-11-10
Brief Title:
Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
Pilot Study Of The Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2015-01
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 presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copiesmL is the main limitation to eradication of the virus from the body This viral reservoir prevents antiretroviral therapy from being interrupted therefore patients are obliged to continue with treatment for a period calculated to be greater than 60 years
Despite the important advances in knowledge of the biology of this reservoir we still have no real knowledge about its dynamics The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional since the results could provide important information on the nature of this reservoir
If maintenance of the reservoir is a dynamic process inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir This effect could be critical when including IAT viral reactivation since in theory it would be necessary to act on a smaller reservoir Current consensus is that it would be necessary to act on almost 100 of the viral reservoir approximately 1000000 cells
The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body
Despite the important advances in knowledge of the biology of this reservoir we still have no real knowledge about its dynamics The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional since the results could provide important information on the nature of this reservoir
If maintenance of the reservoir is a dynamic process inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir This effect could be critical when including IAT viral reactivation since in theory it would be necessary to act on a smaller reservoir Current consensus is that it would be necessary to act on almost 100 of the viral reservoir approximately 1000000 cells
The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body
Detailed Description:
None
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 |
|---|---|---|---|
| Eudra CT 2007-003995-21 | None | None | None |