Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT00834457
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2009-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C554498', 'term': 'AIDS-related Kaposi sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C418262', 'term': 'abacavir, lamivudine, and zidovudine drug combination'}, {'id': 'C106538', 'term': 'abacavir'}, {'id': 'C492871', 'term': 'abacavir, lamivudine drug combination'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-29', 'studyFirstSubmitDate': '2009-02-02', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare effects of twice-daily all-(NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a protease inhibitor AIDS-KS subjects with good virologic suppression on all-NRTI regimen.', 'timeFrame': '96 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["AIDS-related Kaposi's sarcoma", 'antiretroviral therapy'], 'conditions': ["AIDS-related Kaposi's Sarcoma"]}, 'descriptionModule': {'briefSummary': 'Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.\n\nStep 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in response to treatment with antiretroviral therapy and to investigate whether clinical resolution of KS is associated with suppression of KSHV replication.\n\nStep 2 was developed to then evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen.\n\nStep 3 was included to evaluate the clinical, immunological, and virological effects of intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have virological failure on an all NRTI regimen.', 'detailedDescription': 'To identify factors associated with successful treatment of KS with antiretroviral therapy and to determine if highly active antiretroviral therapy improves survival and quality of life for persons with AIDS-KS in Zimbabwe.\n\nA secondary objective is to investigate the durability of HIV-1 suppression by the combination of ABC/3TC/ZDV in persons infected with HIV-1 subtype C and to evaluate the timing and characteristics of mutations in HIV-1 reverse transcriptase in subjects who fail to achieve, or to maintain suppression of HIV-1 replication during treatment with ABC/3TC/ZDV.\n\nAn important objective is to assess adherence to a simplified antiretroviral regimen in a resource-limited setting.\n\nThe study will evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression on ABC/3TC/ZDV (see above).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Completion of at least 96 weeks of treatment with ABC/3TC/ZDV on protocol Step 1.\n\n* Currently receiving ABC/3TC/ZDV on Step 1/initial open-label allNRTI phase of study.\n* Plasma HIV-1 RNA \\< 400 copies/mL on the most recent plasma HIV-1 RNA performed within 4 weeks of Step 2 entry.\n* Willing to potentially switch to a new antiretroviral regimen.\n* In the opinion of the site investigator currently has clinical evidence of active KS disease.\n\nExclusion Criteria\n\n* None'}, 'identificationModule': {'nctId': 'NCT00834457', 'briefTitle': "A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe", 'organization': {'class': 'OTHER', 'fullName': 'Parirenyatwa Hospital'}, 'officialTitle': "A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe", 'orgStudyIdInfo': {'id': 'COL30512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2A', 'description': 'co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks', 'interventionNames': ['Drug: abacavir/3TC/zidovudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2B', 'description': 'co-formulated abacavir 600mg/3TC 300mg orally (as Kivexa) one tablet daily plus fixed dose lopinavir 133.3mg/ritonavir 33.3mg orally (as Aluvia) four tablets daily for 96 weeks', 'interventionNames': ['Drug: abacavir /3TC plus ritonavir boosted lopinavir']}], 'interventions': [{'name': 'abacavir/3TC/zidovudine', 'type': 'DRUG', 'otherNames': ['Trizivir'], 'description': 'continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks', 'armGroupLabels': ['2A']}, {'name': 'abacavir /3TC plus ritonavir boosted lopinavir', 'type': 'DRUG', 'otherNames': ['Kivexa or Epzicom', 'Aluvia'], 'description': 'fixed dose abacavir 600mg/3TC 300mg one tablet po QD for 96 weeks plus fixed dose ritonavir 33.3mg/lopinavir 133.3mg four tablets po QD for 96 weeks', 'armGroupLabels': ['2B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe College of Health Sciences Department of Medicine', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Margaret Z Borok, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zimbabwe College of Health Sciences Department of Medicine'}, {'name': 'Thomas B Campbell, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parirenyatwa Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Margaret Borok', 'investigatorAffiliation': 'Parirenyatwa Hospital'}}}}