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Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

Primary Purpose

HIV Infections

Status

Terminated

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Standard Continuous Highly Active Antiretroviral Therapy (HAART)

Rapidly Cycled HAART

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, HAART, sequential HAART, resistance, salvage therapy, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

HIV Outpatient Clinic, Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous triple-class therapy

Alternating therapy

Arm Description

Patients will be treated with a regimen containing antiretroviral agents from 3 different classes

Patients will be assigned to weekly alternating dual-class regimen

Outcomes

Primary Outcome Measures

Changes in plasma HIV-1 RNA load

Secondary Outcome Measures

Changes in the genotype of the dominant quasispecies

Replicative fitness of the dominant quasispecies

Changes in CD4+ and CD8+ cell counts

Full Information

NCT ID

NCT00128908

First Posted

August 8, 2005

Last Updated

September 14, 2009

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Dutch AIDS Fund

1. Study Identification

Unique Protocol Identification Number

NCT00128908

Brief Title

Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

Official Title

Sequential HAART in Treatment Resistant HIV-1 Infected Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Terminated

Why Stopped

Did not recruit

Study Start Date

September 2005 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Dutch AIDS Fund

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV-1, HAART, sequential HAART, resistance, salvage therapy, Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous triple-class therapy

Arm Type

Active Comparator

Arm Description

Patients will be treated with a regimen containing antiretroviral agents from 3 different classes

Arm Title

Alternating therapy

Arm Type

Experimental

Arm Description

Patients will be assigned to weekly alternating dual-class regimen

Intervention Type

Drug

Intervention Name(s)

Standard Continuous Highly Active Antiretroviral Therapy (HAART)

Intervention Type

Drug

Intervention Name(s)

Rapidly Cycled HAART

Primary Outcome Measure Information:

Title

Changes in plasma HIV-1 RNA load

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Changes in the genotype of the dominant quasispecies

Time Frame

12 weeks

Title

Replicative fitness of the dominant quasispecies

Time Frame

12 weeks

Title

Changes in CD4+ and CD8+ cell counts

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joep MA Lange, MD PhD

Organizational Affiliation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ferdinand Wit, MD PhD

Organizational Affiliation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official's Role

Study Director

Facility Information:

Facility Name

HIV Outpatient Clinic, Academic Medical Center

City

Amsterdam

State/Province

ZIP/Postal Code

1105AZ

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

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