Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients
Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
Drug: Rapidly Cycled HAART
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sequential HAART in Treatment Resistant HIV-1 Infected Patients|
- Changes in plasma HIV-1 RNA load [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in the genotype of the dominant quasispecies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Replicative fitness of the dominant quasispecies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in CD4+ and CD8+ cell counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Continuous triple-class therapy
Patients will be treated with a regimen containing antiretroviral agents from 3 different classes
|Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)|
Experimental: Alternating therapy
Patients will be assigned to weekly alternating dual-class regimen
|Drug: Rapidly Cycled HAART|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128908
|HIV Outpatient Clinic, Academic Medical Center|
|Amsterdam, NH, Netherlands, 1105AZ|
|Study Chair:||Joep MA Lange, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Study Director:||Ferdinand Wit, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|