NCT00192634|CompletedPhase 4DMC
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Sponsor study identifier
Secondary identifiers
interventional
357
1 country
31
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2005
Actual (reported)September 19, 2005
Actual (reported)December 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 2008
Actual (reported)August 2008
Actual (reported)virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart(Roche Amplicor v1.5, LLD 50 copies/mL)
Week 48
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
Week 48 and 96
glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART.
Week 48 and 96
Abacavir 600mg/Lamivudine 300mg
Tenofovir 300mg/emtricitabine 200mg
1 tablet once daily for 96 weeks
1 tablet once daily for 96 weeks
Holdsworth House General Practice - Byron Bay
Byron Bay, New South Wales, 2481, Australia
Lismore Sexual Health Clinic - Northen Rivers Area Health Service
Lismore, New South Wales, 2480, Australia
John Hunter Hospital
Newcastle, New South Wales, 2304, Australia
407 Doctors
Sydney, New South Wales, 2010, Australia
Albion Street Centre
Sydney, New South Wales, 2010, Australia
Holdsworth House General Practice
Sydney, New South Wales, 2010, Australia
St. Vincent's Hospital
Sydney, New South Wales, 2010, Australia
http://www.retroconference.org/AbstractSearch/Default.aspx?Conf=18
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.
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.
Andrew Carr, MD FRACP FRCPA
Kirby Institute
357 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Taylor Square Private Clinic
Sydney, New South Wales, 2010, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Clinic 16, Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Burwood Road Practice
Sydney, New South Wales, 2134, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Liverpool Health Service
Sydney, New South Wales, 2170, Australia
QLD Health - AIDS Medical Unit
Brisbane, Queensland, 4002, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Gladstone Road Medical Centre
Brisbane, Queensland, 4101, Australia
Doll's House Clinic - Cairns Base Hospital
Cairns, Queensland, 4870, Australia
Gold Coast Sexual Health Clinic
Miami, Queensland, 4220, Australia
Clinic 87, Nambour Hospital
Nambour, Queensland, 4560, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Care and Prevention Programme - Adelaide University
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Carlton Clinic
Melbourne, Victoria, 3053, Australia
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053, Australia
Prahran Market Clinic
Melbourne, Victoria, 3141, Australia
Monash Medical Centre
Melbourne, Victoria, 3168, Australia
The Centre Clinic
Melbourne, Victoria, 3182, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3403, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
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.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
May 25, 2011
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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