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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00188851 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Structured Treatment Interruption for HIV Patients With Virologic Failure
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Scientific title:
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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 |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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196 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00188851 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Richard Harrigan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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B.C. Centre of Excellence, Vancouver, B.C. |
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Name:
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Joel Singer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Canadian Trials Network, Vancouver, B.C. |
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Name:
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Sylvie Trottier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique Medicale L'Actuel, Montreal, Quebec |
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Name:
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Bill Cameron, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Hospital, Ottawa, On |
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Name:
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Janet Raboud, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Univeristy Health Network, Toronto, On |
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Name:
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Mona Loutfy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto, On |
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Name:
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Stephen Shafran, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta, Edmonton, Alberta |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Drug: therapeutic management strategy
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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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.
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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
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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).
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5. To determine the impact of the STI on quality of life measures.
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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.
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Secondary ID(s)
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CIHR82716
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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