Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128908
Status:
TERMINATED
Last Update Posted:
2009-09-15
First Post:
2005-08-08
Brief Title:
Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Sequential HAART in Treatment Resistant HIV-1 Infected Patients
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy
Detailed Description:
Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations
This is an open label crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy
The objectives are to study the feasibility safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available
This is an open-label crossover pilot study Patients that fail their current regimen and who currently have no adequate treatment options left will be randomized to start either an alternating triple combination or to start a continuous quadruple regimen of drugs After 6 weeks patients will crossover from either strategy to the other strategy for another 6 weeks Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks In the study period when regimens are alternated two combinations of three drugs with the least possible cross-resistance will alternate every week
This is an open label crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy
The objectives are to study the feasibility safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available
This is an open-label crossover pilot study Patients that fail their current regimen and who currently have no adequate treatment options left will be randomized to start either an alternating triple combination or to start a continuous quadruple regimen of drugs After 6 weeks patients will crossover from either strategy to the other strategy for another 6 weeks Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks In the study period when regimens are alternated two combinations of three drugs with the least possible cross-resistance will alternate every week
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 |
|---|---|---|---|
| 2004040 - Dutch AIDS Fund | None | None | None |