Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT00192634
Status:
COMPLETED
Last Update Posted:
2011-05-25
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'C106538', 'term': 'abacavir'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C492871', 'term': 'abacavir, lamivudine drug combination'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-24', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart(Roche Amplicor v1.5, LLD 50 copies/mL)', 'timeFrame': 'Week 48'}], 'secondaryOutcomes': [{'measure': 'plasma HIV RNA<50copies/mL; time to virological failure (VF); virological resistance in those with VF; all SAEs; use of concomitant meds for toxicity; adherence; QoL; CD4+lymphocyte count; full blood count; biochemistry; lipid parameters', 'timeFrame': 'Week 48 and 96'}, {'measure': 'glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART.', 'timeFrame': 'Week 48 and 96'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Antiretroviral therapy', 'nucleoside analogue reverse transcriptase', 'fixed dose combination', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'http://www.retroconference.org/AbstractSearch/Default.aspx?Conf=18'}, {'pmid': '19842973', 'type': 'RESULT', 'citation': 'Martin A, Bloch M, Amin J, Baker D, Cooper DA, Emery S, Carr A. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-Lamivudine: a randomized, 96-week trial. Clin Infect Dis. 2009 Nov 15;49(10):1591-601. doi: 10.1086/644769.'}, {'pmid': '24722774', 'type': 'DERIVED', 'citation': 'Haskelberg H, Pocock N, Amin J, Ebeling PR, Emery S, Carr A; STEAL study investigators; Allworth A. Hip structural parameters over 96 weeks in HIV-infected adults switching treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS One. 2014 Apr 10;9(4):e94858. doi: 10.1371/journal.pone.0094858. eCollection 2014.'}, {'pmid': '24681993', 'type': 'DERIVED', 'citation': 'Haskelberg H, Cordery DV, Amin J, Kelleher AD, Cooper DA, Emery S; STEAL Study Group. HLA alleles association with changes in bone mineral density in HIV-1-infected adults changing treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS One. 2014 Mar 28;9(3):e93333. doi: 10.1371/journal.pone.0093333. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.med.unsw.edu.au/nchecr/', 'label': 'National Centre in HIV Epidemiology and Clinical Research Homepage'}]}, 'descriptionModule': {'briefSummary': 'Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety.', 'detailedDescription': 'The aim of this study is to compare the overall safety and efficacy of two dual-NRTI, once daily, tablets over a 2 year period in HIV infected adults.\n\nThe study is a randomised, multi-centre, 2 year study of two dual NRTI, once daily tablets in subjects with HIV, currently taking two individual NRTIs as part of their therapy. 350 subjects will be randomised in a 1:1 ratio to either:\n\n1. tenofovir (TDF) 300mg + emtricitabine (FTC) 200mg OR\n2. abacavir (ABC) 600mg + lamivudine (3TC) 300mg. Subjects will cease their current individual NRTI treatment, commence their randomised dual NRTI tablet, and continue on their current NNRTI or PI therapy.\n\nSubjects will be stratified by the type of NRTI they are currently taking (ABC, TDF or other); whether they are currently taking a protease inhibitor (yes or no); and by the site where they are randomised. A study plan is enclosed\n\nSubjects will be closely monitored (at 1 month and then every 3 months until week 96) for safety by evaluating the incidence and severity of adverse effects/abnormal laboratory parameters. Study investigations enclosed. It is optional whether subjects also provide plasma, serum and cells (PBMCs) for storage. These samples will be available for analysis for sub-studies agreed to through the IVRN expression of interest network.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented HIV infection\n* age at least 18 years\n* stable (≥ to 12 weeks) ART including at least two NRTIs, currently well tolerated, with no plan to change any other component of the ART regimen at or after baseline\n* HIV RNA \\< 50 copies/mL plasma for the preceding 12 weeks\n* GFR ≥ 70 mL/min/1.73m2 (estimated by the abbreviated MDRD equation23 estimated GFR = 186 x (\\[SCR/88.4\\]-1.154) x age-0.203 x (0.742 if female) x (1.210 if African-American)\n* provision of written, informed consent\n\nExclusion Criteria:\n\n* HLA-B\\*5701 positive at screening OR evidence of previous ABC hypersensitivity OR clinical failure in participants taking abacavir for at least 30 days\n* current therapy comprising triple NRTI therapy alone\n* current use of ABC/3TC FDC (Kivexa) or TDF/FTC FDC (Truvada)\n* history of non-traumatic osteoporotic fracture\n* prior hypersensitivity or intolerance to ABC, 3TC, TDF or FTC\n* prior clinical failure to a regimen containing ABC or TDF\n* prior use of TDF for control of previously active hepatitis B (HBsAg+ or HBV DNA+) in patients likely to be resistant to 3TC/FTC\n* current therapy including unboosted atazanavir\n* concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents\n* clinical evidence of cirrhosis (e.g. smooth liver, no features of portal hypertension)\n* creatinine clearance \\< 50 mL/min (estimated by the Cockcroft-Gault equation)18,19\n\n * Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)\n * Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)'}, 'identificationModule': {'nctId': 'NCT00192634', 'briefTitle': 'A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study.', 'orgStudyIdInfo': {'id': 'STEAL'}, 'secondaryIdInfos': [{'id': 'ACTRN012605000505606'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Abacavir 600mg/Lamivudine 300mg', 'interventionNames': ['Drug: Abacavir 600mg - Lamivudine 300mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Tenofovir 300mg/emtricitabine 200mg', 'interventionNames': ['Drug: Emtricitabine 200mg - Tenofovir 300mg']}], 'interventions': [{'name': 'Emtricitabine 200mg - Tenofovir 300mg', 'type': 'DRUG', 'otherNames': ['Truvada'], 'description': '1 tablet once daily for 96 weeks', 'armGroupLabels': ['2']}, {'name': 'Abacavir 600mg - Lamivudine 300mg', 'type': 'DRUG', 'otherNames': ['Kivexa'], 'description': '1 tablet once daily for 96 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2481', 'city': 'Byron Bay', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House General Practice - Byron Bay', 'geoPoint': {'lat': -28.64989, 'lon': 153.61246}}, {'zip': '2480', 'city': 'Lismore', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Lismore Sexual Health Clinic - Northen Rivers Area Health Service', 'geoPoint': {'lat': -28.81354, 'lon': 153.2773}}, {'zip': '2304', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'John Hunter Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': '407 Doctors', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Albion Street Centre', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House General Practice', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Taylor Square Private Clinic', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2065', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Clinic 16, Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2134', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Burwood Road Practice', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2170', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Health Service', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4002', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'QLD Health - AIDS Medical Unit', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4101', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gladstone Road Medical Centre', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4870', 'city': 'Cairns', 'state': 'Queensland', 'country': 'Australia', 'facility': "Doll's House Clinic - Cairns Base Hospital", 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}, {'zip': '4220', 'city': 'Miami', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast Sexual Health Clinic', 'geoPoint': {'lat': -28.07173, 'lon': 153.44158}}, {'zip': '4560', 'city': 'Nambour', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinic 87, Nambour Hospital', 'geoPoint': {'lat': -26.62613, 'lon': 152.95941}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Care and Prevention Programme - Adelaide University', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Carlton Clinic', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Melbourne Sexual Health Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3141', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Prahran Market Clinic', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3182', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Centre Clinic', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3403', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fremantle Hospital', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Andrew Carr, MD FRACP FRCPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirby Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Prof Sean Emery', 'oldOrganization': 'The National Centre in HIV Epidemiology and Clinical Research'}}}}