Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

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

Status and phase: Terminated; Phase 4

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00128908

05IAT0061

2004040 - Dutch AIDS Fund

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Continuous triple-class therapy

Active Comparator group

Description:

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

Treatment:

Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)

Alternating therapy

Experimental group

Description:

Patients will be assigned to weekly alternating dual-class regimen

Treatment:

Drug: Rapidly Cycled HAART