Structured Treatment Interruption for HIV Patients With Virologic Failure

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV	Drug: therapeutic management strategy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	196 participants
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
Study Start Date :	January 2001
Study Completion Date :	November 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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. 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. 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. 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. 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. 5. To determine the impact of the STI on quality of life measures.
6. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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 prednisone. This excludes a short course of inhaled or oral steroids for asthma exacerbation)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00188851 History of Changes
Other Study ID Numbers:	CIHR82716
First Posted:	September 16, 2005
Last Update Posted:	September 16, 2005
Last Verified:	September 2005

Keywords provided by University Health Network, Toronto:

HIV; salvage regimen; virologic failure; treatment interruption; ARV experienced