Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

HIV Infections Clinical Trial

Official title:

Sequential HAART in Treatment Resistant HIV-1 Infected Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00128908
• Other study ID #: 05IAT0061
• Secondary ID: 2004040 - Dutch
• Status: Terminated
• Phase: Phase 4
• First received: August 8, 2005
• Last updated: September 14, 2009
• Start date: September 2005
• Est. completion date: January 2007

Study information

• Verified date: September 2009
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Standard Continuous Highly Active Antiretroviral Therapy (HAART)

• Rapidly Cycled HAART

Locations

Country	Name	City	State
Netherlands	HIV Outpatient Clinic, Academic Medical Center	Amsterdam	NH

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Dutch AIDS Fund

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma HIV-1 RNA load		12 weeks	No
Secondary	Changes in the genotype of the dominant quasispecies		12 weeks	No
Secondary	Replicative fitness of the dominant quasispecies		12 weeks	No
Secondary	Changes in CD4+ and CD8+ cell counts		12 weeks	No