Clinical Trials
Structured Treatment Interruption for HIV Patients With Virologic Failure
Sponsor
University Health Network, Toronto
Collaborator
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party)
University Health Network, Toronto
NCT00188851
First received: September 12, 2005
Last updated: September 12, 2005
Last Verified: September 2005
History of Changes
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 Intervention Model: Parallel Assignment Masking: None (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 |
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.
- 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.
Enrollment: | 196 |
Study Start Date: | January 2001 |
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 | |
Sexes Eligible for Study: | All | |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.Please refer to this study by its ClinicalTrials.gov identifier: NCT00188851
Sponsors and Collaborators
University Health Network, TorontoCanadian 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
Responsible Party: | University Health Network, Toronto | |
ClinicalTrials.gov Identifier: | NCT00188851 History of Changes | |
Other Study ID Numbers: | CIHR82716 | |
Study First Received: | September 12, 2005 | |
Last Updated: | September 12, 2005 |
Keywords provided by University Health Network, Toronto:
HIVsalvage regimen
virologic failure
treatment interruption
ARV experienced
ClinicalTrials.gov processed this data on April 24, 2018
This information is provided by ClinicalTrials.gov.