Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

Sequential HAART in Treatment Resistant HIV-1 Infected Patients

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128908

Enrollment

Registered

2005-08-10

Start date

2005-09-30

Completion date

2007-01-31

Last updated

2009-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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.

Interventions

DRUGStandard Continuous Highly Active Antiretroviral Therapy (HAART)

DRUGRapidly Cycled HAART

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Changes in plasma HIV-1 RNA load	12 weeks

Secondary

Measure	Time frame
Changes in the genotype of the dominant quasispecies	12 weeks
Replicative fitness of the dominant quasispecies	12 weeks
Changes in CD4+ and CD8+ cell counts	12 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026