A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study
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ClinicalTrials.gov Identifier: NCT00192634 |
Recruitment Status
:
Completed
First Posted
: September 19, 2005
Last Update Posted
: May 25, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Emtricitabine 200mg - Tenofovir 300mg Drug: Abacavir 600mg - Lamivudine 300mg | Phase 4 |
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.
The 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:
- tenofovir (TDF) 300mg + emtricitabine (FTC) 200mg OR
- 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.
Subjects 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
Subjects 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 357 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study. |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Abacavir 600mg/Lamivudine 300mg
|
Drug: Abacavir 600mg - Lamivudine 300mg
1 tablet once daily for 96 weeks
Other Name: Kivexa
|
Active Comparator: 2
Tenofovir 300mg/emtricitabine 200mg
|
Drug: Emtricitabine 200mg - Tenofovir 300mg
1 tablet once daily for 96 weeks
Other Name: Truvada
|
- virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart(Roche Amplicor v1.5, LLD 50 copies/mL) [ Time Frame: 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 [ Time Frame: Week 48 and 96 ]
- glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART. [ Time Frame: Week 48 and 96 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- documented HIV infection
- age at least 18 years
- 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
- HIV RNA < 50 copies/mL plasma for the preceding 12 weeks
- 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)
- provision of written, informed consent
Exclusion Criteria:
- HLA-B*5701 positive at screening OR evidence of previous ABC hypersensitivity OR clinical failure in participants taking abacavir for at least 30 days
- current therapy comprising triple NRTI therapy alone
- current use of ABC/3TC FDC (Kivexa) or TDF/FTC FDC (Truvada)
- history of non-traumatic osteoporotic fracture
- prior hypersensitivity or intolerance to ABC, 3TC, TDF or FTC
- prior clinical failure to a regimen containing ABC or TDF
- prior use of TDF for control of previously active hepatitis B (HBsAg+ or HBV DNA+) in patients likely to be resistant to 3TC/FTC
- current therapy including unboosted atazanavir
- concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents
- clinical evidence of cirrhosis (e.g. smooth liver, no features of portal hypertension)
-
creatinine clearance < 50 mL/min (estimated by the Cockcroft-Gault equation)18,19
- Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)
- Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in µmol/L)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192634
Australia, New South Wales | |
Holdsworth House General Practice - Byron Bay | |
Byron Bay, New South Wales, Australia, 2481 | |
Lismore Sexual Health Clinic - Northen Rivers Area Health Service | |
Lismore, New South Wales, Australia, 2480 | |
John Hunter Hospital | |
Newcastle, New South Wales, Australia, 2304 | |
407 Doctors | |
Sydney, New South Wales, Australia, 2010 | |
Albion Street Centre | |
Sydney, New South Wales, Australia, 2010 | |
Holdsworth House General Practice | |
Sydney, New South Wales, Australia, 2010 | |
St. Vincent's Hospital | |
Sydney, New South Wales, Australia, 2010 | |
Taylor Square Private Clinic | |
Sydney, New South Wales, Australia, 2010 | |
Prince of Wales Hospital | |
Sydney, New South Wales, Australia, 2031 | |
Clinic 16, Royal North Shore Hospital | |
Sydney, New South Wales, Australia, 2065 | |
Burwood Road Practice | |
Sydney, New South Wales, Australia, 2134 | |
Westmead Hospital | |
Sydney, New South Wales, Australia, 2145 | |
Liverpool Health Service | |
Sydney, New South Wales, Australia, 2170 | |
Australia, Queensland | |
QLD Health - AIDS Medical Unit | |
Brisbane, Queensland, Australia, 4002 | |
Royal Brisbane and Women's Hospital | |
Brisbane, Queensland, Australia, 4029 | |
Gladstone Road Medical Centre | |
Brisbane, Queensland, Australia, 4101 | |
Doll's House Clinic - Cairns Base Hospital | |
Cairns, Queensland, Australia, 4870 | |
Gold Coast Sexual Health Clinic | |
Miami, Queensland, Australia, 4220 | |
Clinic 87, Nambour Hospital | |
Nambour, Queensland, Australia, 4560 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
The Care and Prevention Programme - Adelaide University | |
Adelaide, South Australia, Australia, 5000 | |
Flinders Medical Centre | |
Adelaide, South Australia, Australia, 5042 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Carlton Clinic | |
Melbourne, Victoria, Australia, 3053 | |
Melbourne Sexual Health Centre | |
Melbourne, Victoria, Australia, 3053 | |
Prahran Market Clinic | |
Melbourne, Victoria, Australia, 3141 | |
Monash Medical Centre | |
Melbourne, Victoria, Australia, 3168 | |
The Centre Clinic | |
Melbourne, Victoria, Australia, 3182 | |
Royal Melbourne Hospital | |
Melbourne, Victoria, Australia, 3403 | |
Australia, Western Australia | |
Fremantle Hospital | |
Fremantle, Western Australia, Australia, 6160 | |
Royal Perth Hospital | |
Perth, Western Australia, Australia, 6000 |
Principal Investigator: | Andrew Carr, MD FRACP FRCPA | Kirby Institute |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof Sean Emery, The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00192634 History of Changes |
Other Study ID Numbers: |
STEAL ACTRN012605000505606 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | May 25, 2011 |
Last Verified: | May 2011 |
Keywords provided by Kirby Institute:
HIV Antiretroviral therapy nucleoside analogue reverse transcriptase fixed dose combination Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Lamivudine Emtricitabine |
Abacavir Dideoxynucleosides Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites |