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Structured Treatment Interruption for HIV Patients With Virologic Failure

NCT ID: NCT00188851

Last Updated: 2005-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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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.

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.

Conditions

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HIV

Keywords

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HIV salvage regimen virologic failure treatment interruption ARV experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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therapeutic management strategy

Intervention Type DRUG

Eligibility 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Mona Loutfy, MD

Role: STUDY_CHAIR

University Health Network, Toronto, On

Joel Singer, MD

Role: STUDY_DIRECTOR

Canadian Trials Network, Vancouver, B.C.

Janet Raboud, Dr.

Role: STUDY_DIRECTOR

Univeristy Health Network, Toronto, On

Stephen Shafran, MD

Role: STUDY_DIRECTOR

University of Alberta, Edmonton, Alberta

Bill Cameron, MD

Role: STUDY_DIRECTOR

Ottawa Hospital, Ottawa, On

Sylvie Trottier, MD

Role: STUDY_DIRECTOR

Clinique Medicale L'Actuel, Montreal, Quebec

Richard Harrigan, MD

Role: STUDY_DIRECTOR

B.C. Centre of Excellence, Vancouver, B.C.

Other Identifiers

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CIHR82716

Identifier Type: -

Identifier Source: org_study_id