NCT00128908

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

August 8, 2005

Last Update Submit

September 14, 2009

Conditions

HIV Infections

Keywords

HIV-1HAARTsequential HAARTresistancesalvage therapyTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma HIV-1 RNA load

    12 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Continuous triple-class therapy

ACTIVE COMPARATOR

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

Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)

Alternating therapy

EXPERIMENTAL

Patients will be assigned to weekly alternating dual-class regimen

Drug: Rapidly Cycled HAART

Interventions

Standard Continuous Highly Active Antiretroviral Therapy (HAART)DRUG
Continuous triple-class therapy
Rapidly Cycled HAARTDRUG
Alternating therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV Outpatient Clinic, Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Joep MA Lange, MD PhD

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

    STUDY CHAIR

  • Ferdinand Wit, MD PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 10, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

NL(1)