A Phase 4 interventional study of Standard Continuous Highly Active Antiretroviral Therapy (HAART) and Rapidly Cycled HAART in HIV Infections, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-15.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 4, Interventional, and Treatment
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 3 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Inclusion Criteria:
Patients will be treated with a regimen containing antiretroviral agents from 3 different classes
Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
Patients will be assigned to weekly alternating dual-class regimen
Drug: Rapidly Cycled HAART
Changes in plasma HIV-1 RNA load
Time frame: 12 weeks
Changes in the genotype of the dominant quasispecies
Time frame: 12 weeks
Replicative fitness of the dominant quasispecies
Time frame: 12 weeks
Changes in CD4+ and CD8+ cell counts
Time frame: 12 weeks
This study is terminated, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)