Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 8, 2005

Last Updated Date

January 19, 2006

Start Date ^†

September 2005

Current Primary Outcome Measures ^†

Changes in plasma HIV-1 RNA load

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00128908 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Changes in the genotype of the dominant quasispecies
Replicative fitness of the dominant quasispecies
Changes in CD4+ and CD8+ cell counts

Original Secondary Outcome Measures ^†

- Replicative fitness of the dominant quasispecies
- Changes in the genotype of the dominant quasispecies
- Changes in CD4+ and CD8+ cell counts

Descriptive Information

Brief Title ^†

Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

Official Title ^†

Sequential HAART in Treatment Resistant HIV-1 Infected Patients

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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

HIV Infections

Intervention ^†

Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
Drug: Rapidly Cycled HAART

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Radjin Steingrover, MD

+31205667188

r.steingrover@amc.uva.nl

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00128908

Responsible Party

Secondary IDs ^††

2004040 - Dutch AIDS Fund

Study Sponsor ^†

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

Collaborators ^††

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)

Information Provided By

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

Verification Date

January 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.