Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

This study has been terminated.
(Did not recruit)
Sponsor:
Collaborator:
Dutch AIDS Fund
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT00128908
First received: August 8, 2005
Last updated: September 14, 2009
Last verified: September 2009

August 8, 2005
September 14, 2009
September 2005
January 2007   (final data collection date for primary outcome measure)
Changes in plasma HIV-1 RNA load [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in plasma HIV-1 RNA load.
Complete list of historical versions of study NCT00128908 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Changes in the genotype of the dominant quasispecies
  • - Replicative fitness of the dominant quasispecies
  • - Changes in CD4+ and CD8+ cell counts
Not Provided
Not Provided
 
Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients
Sequential HAART in Treatment Resistant HIV-1 Infected Patients

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
  • Drug: Rapidly Cycled HAART
  • Active Comparator: Continuous triple-class therapy
    Patients will be treated with a regimen containing antiretroviral agents from 3 different classes
    Intervention: Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
  • Experimental: Alternating therapy
    Patients will be assigned to weekly alternating dual-class regimen
    Intervention: Drug: Rapidly Cycled HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infected patients
  • At least 18 years of age
  • Males or non-pregnant, non-lactating females
  • Documented virological treatment failure on at least 3 classes of antiretroviral drugs
  • No adequate antiretroviral therapy possible with currently available antiretroviral agents
  • Virological treatment failure is defined as plasma HIV-1 RNA levels > 5000 while taking at least three different antiretroviral drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00128908
05IAT0061, 2004040 - Dutch AIDS Fund
No
Prof. J. Prins, Academic Medical Center, Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch AIDS Fund
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)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP