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Sponsors and Collaborators: |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Dutch AIDS Fund |
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Information provided by: | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT00128908 |
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 |
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HIV Infections |
Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART) Drug: Rapidly Cycled HAART |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Sequential HAART in Treatment Resistant HIV-1 Infected Patients |
Estimated Enrollment: | 12 |
Study Start Date: | September 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Radjin Steingrover, MD | +31205667188 | r.steingrover@amc.uva.nl |
Netherlands, NH | |
HIV Outpatient Clinic, Academic Medical Center | Recruiting |
Amsterdam, NH, Netherlands, 1105AZ | |
Contact: Radjin Steingrover, MD +31205667188 r.steingrover@amc.uva.nl | |
Principal Investigator: Jan Prins, MD PhD |
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) |
Study ID Numbers: | 05IAT0061, 2004040 - Dutch AIDS Fund |
Study First Received: | August 8, 2005 |
Last Updated: | January 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00128908 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
HIV-1 HAART sequential HAART |
resistance salvage therapy Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |