Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous triple-class therapy

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

Group Type ACTIVE_COMPARATOR

Standard Continuous Highly Active Antiretroviral Therapy (HAART)

Intervention Type DRUG

Alternating therapy

Patients will be assigned to weekly alternating dual-class regimen

Group Type EXPERIMENTAL

Rapidly Cycled HAART

Intervention Type DRUG

Interventions

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Standard Continuous Highly Active Antiretroviral Therapy (HAART)

Intervention Type DRUG

Rapidly Cycled HAART

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No