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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
Drug: Rapidly Cycled HAART
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Changes in plasma HIV-1 RNA load [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: September 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128908

Locations
Netherlands
HIV Outpatient Clinic, Academic Medical Center
Amsterdam, NH, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch AIDS Fund
Investigators
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)
  More Information

No publications provided

Responsible Party: Prof. J. Prins, Academic Medical Center, Amsterdam
ClinicalTrials.gov Identifier: NCT00128908     History of Changes
Other Study ID Numbers: 05IAT0061, 2004040 - Dutch AIDS Fund
Study First Received: August 8, 2005
Last Updated: September 14, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
HIV-1
HAART
sequential HAART
resistance
salvage therapy
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 31, 2014