Structured Treatment Interruption for HIV Patients With Virologic Failure

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188851
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.

Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.


Condition Intervention
HIV
Drug: therapeutic management strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Structured Treatment Interruption(STI) Followed by Initiation of a New Antiretroviral Regimen(ARV) Versus Immediate Switching to a New ARV in HIV-Infected Patients Experiencing Virologic Failure on HAART

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.

Secondary Outcome Measures:
  • 1. To prospectively determine differences in other virologic parameters through follow up between patients being switched to a salvage regimen with or without a STI.
  • 2. To prospectively determine differences in change in CD4 count through follow up and at 24, 48 and 60 weeks following randomization between patients being switched to a salvage regimen with or without a STI.
  • 3. To prospectively determine differences in the development or reactivation of opportunistic infections and survival between patients being switched to a salvage regimen with or without a STI at 60 weeks following randomization
  • 4. To determine the proportion of virus of patients being treated with a STI that converts to wild-type and how that relates to the virologic response (% of patients with undetectable viral load sustained for 3 months).
  • 5. To determine the impact of the STI on quality of life measures.
  • 6. To determine the genotypic resistance pattern of virus from patients who fail treatment after suppression to <50 copies/mL on the salvage regimen and to compare results in those who do and do not receive an STI.

Estimated Enrollment: 196
Study Start Date: January 2001
Estimated Study Completion Date: November 2005
Detailed Description:

To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.

Hypothesis: By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.

Interventions:

Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.

Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • On therapy with a triple ARV that includes a protease inhibitor and/or non-nucleoside reverse transcriptase inhibitor for the past 3 months with no changes in any agent of the combination in the past 14 days.
  • Virologic failure while on the combination as defined by a plasma HIV RNA > 1000 copies/mL measured on 2 occasions at least 4 weeks apart.
  • HIV RNA <500,000 copies/mL.
  • CD4 cell count must be > 50/mm3
  • Patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days.
  • The patient has at least two new ARV available based on history, and at least two of these new agents will be included in the new salvage regimen.

Exclusion Criteria:

  • Active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance.
  • Pregnancy or breast feeding.
  • Patients with any of the following abnormal laboratory test results at screening:· Hemoglobin<80 g/L, neutrophil count<750 cells/mL, Platelet<20,000 /mL· AST or ALT > 5X Upper Limit of Normal (ULN)· Creatinine > 250 umol/L
  • End stage organ disease
  • Patient with malignancy receiving systemic chemotherapy
  • Patient has need for immune modulators (interleukin, interferon, GMCSF etc) or prednisone. This excludes a short course of inhaled or oral steroids for asthma exacerbation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188851

Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Investigators
Study Chair: Mona Loutfy, MD University Health Network, Toronto, On
Study Director: Joel Singer, MD Canadian Trials Network, Vancouver, B.C.
Study Director: Janet Raboud, Dr. Univeristy Health Network, Toronto, On
Study Director: Stephen Shafran, MD University of Alberta, Edmonton, Alberta
Study Director: Bill Cameron, MD Ottawa Hospital, Ottawa, On
Study Director: Sylvie Trottier, MD Clinique Medicale L'Actuel, Montreal, Quebec
Study Director: Richard Harrigan, MD B.C. Centre of Excellence, Vancouver, B.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188851     History of Changes
Other Study ID Numbers: CIHR82716
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
HIV
salvage regimen
virologic failure
treatment interruption
ARV experienced

ClinicalTrials.gov processed this record on April 20, 2014