Ignite Creation Date:
2024-05-05 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00646984
Status:
COMPLETED
Last Update Posted:
2008-03-31
First Post:
2008-03-26
Brief Title:
Strategies of InterruptionReinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Comparison of Strategies of InterruptionReinitiation of Antiretroviral Therapy in Response to ImmunologicVirologic Changes in HIV-Infected Patients With Lipodystrophy
Status:
COMPLETED
Status Verified Date:
2008-03
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:
Aim To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons
Design Pilot prospective open randomized controlled 3-year study
Setting and patients University hospital Patients with viral load 200 copiesmL and CD4 cell count 450mm3 for at least the last 3 months Three arms with 50 patients each that will be randomized either to continue antiretroviral therapy or to discontinue it as long as either HIV-1 RNA be lower than 30000 copiesmL or CD4 cell count be higher than 300mm3
Study end-points evolution of plasma metabolic parameters body fat and bone mineral density incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome incidence of virological failure plasma HIV-1 RNA 200 copiesmL while on therapy immunological failure CD4 cell count 200mm3 while on therapy or clinical failure development of AIDS-defining illnesses cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV
Design Pilot prospective open randomized controlled 3-year study
Setting and patients University hospital Patients with viral load 200 copiesmL and CD4 cell count 450mm3 for at least the last 3 months Three arms with 50 patients each that will be randomized either to continue antiretroviral therapy or to discontinue it as long as either HIV-1 RNA be lower than 30000 copiesmL or CD4 cell count be higher than 300mm3
Study end-points evolution of plasma metabolic parameters body fat and bone mineral density incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome incidence of virological failure plasma HIV-1 RNA 200 copiesmL while on therapy immunological failure CD4 cell count 200mm3 while on therapy or clinical failure development of AIDS-defining illnesses cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV
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 |
|---|---|---|---|
| AEM 01-0480 | None | None | None |