Status:
COMPLETED
Structured Treatment Interruption for HIV Patients With Virologic Failure
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00188851
Start Date
January 1 2001
End Date
November 1 2005
Last Update
September 16 2005
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