Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00188851
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structured Treatment Interruption for HIV Patients With Virologic Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.'}], 'secondaryOutcomes': [{'measure': '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.'}, {'measure': '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.'}, {'measure': '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'}, {'measure': '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).'}, {'measure': '5. To determine the impact of the STI on quality of life measures.'}, {'measure': '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.'}]}, 'conditionsModule': {'keywords': ['HIV', 'salvage regimen', 'virologic failure', 'treatment interruption', 'ARV experienced'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.', 'detailedDescription': '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.\n\nHypothesis: 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.\n\nInterventions:\n\nImmediate 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.\n\nStructured 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years.\n* 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.\n* 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.\n* HIV RNA \\<500,000 copies/mL.\n* CD4 cell count must be \\> 50/mm3\n* Patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days.\n* 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.\n\nExclusion Criteria:\n\n* Active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance.\n* Pregnancy or breast feeding.\n* 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\n* End stage organ disease\n* Patient with malignancy receiving systemic chemotherapy\n* 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)"}, 'identificationModule': {'nctId': 'NCT00188851', 'briefTitle': 'Structured Treatment Interruption for HIV Patients With Virologic Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CIHR82716'}}, 'armsInterventionsModule': {'interventions': [{'name': 'therapeutic management strategy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mona Loutfy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Health Network, Toronto, On'}, {'name': 'Joel Singer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Canadian Trials Network, Vancouver, B.C.'}, {'name': 'Janet Raboud, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univeristy Health Network, Toronto, On'}, {'name': 'Stephen Shafran, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alberta, Edmonton, Alberta'}, {'name': 'Bill Cameron, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ottawa Hospital, Ottawa, On'}, {'name': 'Sylvie Trottier, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Clinique Medicale L'Actuel, Montreal, Quebec"}, {'name': 'Richard Harrigan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'B.C. Centre of Excellence, Vancouver, B.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'CIHR Canadian HIV Trials Network', 'class': 'NETWORK'}]}}}