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Trial registered on ANZCTR


Registration number
ACTRN12605000505606
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The STEAL Study
Scientific title
A randomised, open-label trial to assess the safety and efficacy of switching to tenofovir-emtricitabine or abacavir-lamivudine in HIV: The STEAL study.
Universal Trial Number (UTN)
Trial acronym
STEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 630 0
Condition category
Condition code
Infection 702 702 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 585 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 855 0
Virological failure defined by HIV RNA > 400 copies/mL plasma on two consecutive occasions greater than or equal to 4 weeks apart (Roche Amplicor version 1.5, LLD 50 copies/mL)
Timepoint [1] 855 0
Secondary outcome [1] 1698 0
1. plasma HIV RNA <50 copies/mL
Timepoint [1] 1698 0
Secondary outcome [2] 1699 0
2. time to virological failure
Timepoint [2] 1699 0
Secondary outcome [3] 1700 0
3. virological resistance in those with virological failure
Timepoint [3] 1700 0
Secondary outcome [4] 1701 0
4. all serious adverse events, regardless of causality
Timepoint [4] 1701 0
Secondary outcome [5] 1702 0
5. clinical adverse events (all grades and grade 3-4), regardless of causality
Timepoint [5] 1702 0
Secondary outcome [6] 1703 0
6. use of concomitant medications for toxicity
Timepoint [6] 1703 0
Secondary outcome [7] 1704 0
7. adherence (clinician assessed)
Timepoint [7] 1704 0
Secondary outcome [8] 1705 0
8. quality of life (SF-8)
Timepoint [8] 1705 0
Secondary outcome [9] 1706 0
9. CD4+ lymphocyte count
Timepoint [9] 1706 0
Secondary outcome [10] 1707 0
10. full blood count
Timepoint [10] 1707 0
Secondary outcome [11] 1708 0
11. biochemistry
Timepoint [11] 1708 0
Secondary outcome [12] 1709 0
12. lipid parameters
Timepoint [12] 1709 0
Secondary outcome [13] 1710 0
13. glycaemic parameters
Timepoint [13] 1710 0
Secondary outcome [14] 1711 0
14. DEXA parameters
Timepoint [14] 1711 0
Secondary outcome [15] 1712 0
15. non-traumatic bone fractures
Timepoint [15] 1712 0
Secondary outcome [16] 1713 0
16. resolution of adverse events (e.g. dyslipidaemia, low BMD, diabetes)
Timepoint [16] 1713 0
Secondary outcome [17] 1714 0
17. progression to AIDS (Category C)
Timepoint [17] 1714 0
Secondary outcome [18] 1715 0
18. death
Timepoint [18] 1715 0
Secondary outcome [19] 1716 0
19. discontinuation of any ART component
Timepoint [19] 1716 0

Eligibility
Key inclusion criteria
1. documented HIV infection2. age at least 18 years3. stable (greater than or equal 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 baseline4. HIV RNA < 50 copies/mL plasma for the preceding 12 weeks5. GFR greater than or equal to 70 mL/min/1.73m2 (estimated by the abbreviated MDRD equation23estimated GFR = 186 x ([SCR/88.4]-1.154) x age-0.203 x (0.742 if female) x (1.210 if African-American)6. provision of written, informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. HLA-B57*01 positive at or prior to screening OR evidence of previous hypersensitivity or clinical failure with abacavir2. current therapy comprising triple NRTI therapy alone3. current use of ABC/3TC FDC (Kivexa) or TDF/FTC FDC (Truvada)4. pregnancy or breast feeding5. history of osteoporotic fracture6. prior hypersensitivity or intolerance to ABC, 3TC, TDF or FTC7. prior clinical failure to a regimen containing ABC or TDF8. prior use of TDF for control of previously active hepatitis B (HBsAg+ or HBV DNA+) in patients likely to be resistant to 3TC/FTC9. current therapy including unboosted atazanavir10. concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents11. clinical evidence of cirrhosis (e.g. smooth liver, no features of portal hypertension)12. creatinine clearance < 50 mL/min (estimated by the Cockcroft-Gault equation)Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 0.814 x (serum creatinine in ÿµmol/L)Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in ÿµmol/L).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomised in a 1:1 ratio to one of two interventional arms. The study is open-label. The randomisation will be automatically performed via a computer program when the subject completes screening. The computer program is part of an online case report form system accessed at all study sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. 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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 777 0
Self funded/Unfunded
Name [1] 777 0
Country [1] 777 0
Primary sponsor type
Government body
Name
The National Centre in HIV Epidemiology and Clinical Research
Address
Country
Australia
Secondary sponsor category [1] 643 0
University
Name [1] 643 0
University of New South Wales
Address [1] 643 0
Country [1] 643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2021 0
Lismore Sexual Health Clinic.
Ethics committee address [1] 2021 0
Ethics committee country [1] 2021 0
Australia
Date submitted for ethics approval [1] 2021 0
Approval date [1] 2021 0
Ethics approval number [1] 2021 0
Ethics committee name [2] 2022 0
John Hunter Hospital
Ethics committee address [2] 2022 0
Ethics committee country [2] 2022 0
Australia
Date submitted for ethics approval [2] 2022 0
Approval date [2] 2022 0
Ethics approval number [2] 2022 0
Ethics committee name [3] 2023 0
Royal North Shore Hospital
Ethics committee address [3] 2023 0
Ethics committee country [3] 2023 0
Australia
Date submitted for ethics approval [3] 2023 0
Approval date [3] 2023 0
Ethics approval number [3] 2023 0
Ethics committee name [4] 2024 0
Holdsworth House GP
Ethics committee address [4] 2024 0
Ethics committee country [4] 2024 0
Australia
Date submitted for ethics approval [4] 2024 0
Approval date [4] 2024 0
Ethics approval number [4] 2024 0
Ethics committee name [5] 2025 0
Burwood Road Practice.
Ethics committee address [5] 2025 0
Ethics committee country [5] 2025 0
Australia
Date submitted for ethics approval [5] 2025 0
Approval date [5] 2025 0
Ethics approval number [5] 2025 0
Ethics committee name [6] 2026 0
St. Vincents Hospital
Ethics committee address [6] 2026 0
Ethics committee country [6] 2026 0
Australia
Date submitted for ethics approval [6] 2026 0
Approval date [6] 2026 0
Ethics approval number [6] 2026 0
Ethics committee name [7] 2027 0
Westmead Hospital.
Ethics committee address [7] 2027 0
Ethics committee country [7] 2027 0
Australia
Date submitted for ethics approval [7] 2027 0
Approval date [7] 2027 0
Ethics approval number [7] 2027 0
Ethics committee name [8] 2028 0
Taylor Square Private Clinic
Ethics committee address [8] 2028 0
Ethics committee country [8] 2028 0
Australia
Date submitted for ethics approval [8] 2028 0
Approval date [8] 2028 0
Ethics approval number [8] 2028 0
Ethics committee name [9] 2029 0
Prince of Wales Hospital
Ethics committee address [9] 2029 0
Ethics committee country [9] 2029 0
Australia
Date submitted for ethics approval [9] 2029 0
Approval date [9] 2029 0
Ethics approval number [9] 2029 0
Ethics committee name [10] 2030 0
Albion Street Centre
Ethics committee address [10] 2030 0
Ethics committee country [10] 2030 0
Australia
Date submitted for ethics approval [10] 2030 0
Approval date [10] 2030 0
Ethics approval number [10] 2030 0
Ethics committee name [11] 2031 0
407 Doctors
Ethics committee address [11] 2031 0
Ethics committee country [11] 2031 0
Australia
Date submitted for ethics approval [11] 2031 0
Approval date [11] 2031 0
Ethics approval number [11] 2031 0
Ethics committee name [12] 2032 0
Liverpool Health Service.
Ethics committee address [12] 2032 0
Ethics committee country [12] 2032 0
Australia
Date submitted for ethics approval [12] 2032 0
Approval date [12] 2032 0
Ethics approval number [12] 2032 0
Ethics committee name [13] 2033 0
Nambour Hospital.
Ethics committee address [13] 2033 0
Ethics committee country [13] 2033 0
Australia
Date submitted for ethics approval [13] 2033 0
Approval date [13] 2033 0
Ethics approval number [13] 2033 0
Ethics committee name [14] 2034 0
Cairns Base Hospital.
Ethics committee address [14] 2034 0
Ethics committee country [14] 2034 0
Australia
Date submitted for ethics approval [14] 2034 0
Approval date [14] 2034 0
Ethics approval number [14] 2034 0
Ethics committee name [15] 2035 0
Gold Coast Sexual Health Clinic
Ethics committee address [15] 2035 0
Ethics committee country [15] 2035 0
Australia
Date submitted for ethics approval [15] 2035 0
Approval date [15] 2035 0
Ethics approval number [15] 2035 0
Ethics committee name [16] 2036 0
AIDS Medical Unit
Ethics committee address [16] 2036 0
Ethics committee country [16] 2036 0
Australia
Date submitted for ethics approval [16] 2036 0
Approval date [16] 2036 0
Ethics approval number [16] 2036 0
Ethics committee name [17] 2037 0
Royal Brisbane and Women's Hospital.
Ethics committee address [17] 2037 0
Ethics committee country [17] 2037 0
Australia
Date submitted for ethics approval [17] 2037 0
Approval date [17] 2037 0
Ethics approval number [17] 2037 0
Ethics committee name [18] 2038 0
Gladstone Road Medical Centre,
Ethics committee address [18] 2038 0
Ethics committee country [18] 2038 0
Australia
Date submitted for ethics approval [18] 2038 0
Approval date [18] 2038 0
Ethics approval number [18] 2038 0
Ethics committee name [19] 2039 0
Royal Adelaide Hospital.
Ethics committee address [19] 2039 0
Ethics committee country [19] 2039 0
Australia
Date submitted for ethics approval [19] 2039 0
Approval date [19] 2039 0
Ethics approval number [19] 2039 0
Ethics committee name [20] 2040 0
Flinders Medical Centre
Ethics committee address [20] 2040 0
Ethics committee country [20] 2040 0
Australia
Date submitted for ethics approval [20] 2040 0
Approval date [20] 2040 0
Ethics approval number [20] 2040 0
Ethics committee name [21] 2041 0
The Care and Prevention Program, Adelaide University
Ethics committee address [21] 2041 0
Ethics committee country [21] 2041 0
Australia
Date submitted for ethics approval [21] 2041 0
Approval date [21] 2041 0
Ethics approval number [21] 2041 0
Ethics committee name [22] 2042 0
Melbourne Sexual Health Centre.
Ethics committee address [22] 2042 0
Ethics committee country [22] 2042 0
Australia
Date submitted for ethics approval [22] 2042 0
Approval date [22] 2042 0
Ethics approval number [22] 2042 0
Ethics committee name [23] 2043 0
Carlton Clinic.
Ethics committee address [23] 2043 0
Ethics committee country [23] 2043 0
Australia
Date submitted for ethics approval [23] 2043 0
Approval date [23] 2043 0
Ethics approval number [23] 2043 0
Ethics committee name [24] 2044 0
The Alfred Hospital.
Ethics committee address [24] 2044 0
Ethics committee country [24] 2044 0
Australia
Date submitted for ethics approval [24] 2044 0
Approval date [24] 2044 0
Ethics approval number [24] 2044 0
Ethics committee name [25] 2045 0
Royal Melbourne Hospital.
Ethics committee address [25] 2045 0
Ethics committee country [25] 2045 0
Australia
Date submitted for ethics approval [25] 2045 0
Approval date [25] 2045 0
Ethics approval number [25] 2045 0
Ethics committee name [26] 2046 0
Prahran Market Clinic.
Ethics committee address [26] 2046 0
Ethics committee country [26] 2046 0
Australia
Date submitted for ethics approval [26] 2046 0
Approval date [26] 2046 0
Ethics approval number [26] 2046 0
Ethics committee name [27] 2047 0
The Centre Clinic.
Ethics committee address [27] 2047 0
Ethics committee country [27] 2047 0
Australia
Date submitted for ethics approval [27] 2047 0
Approval date [27] 2047 0
Ethics approval number [27] 2047 0
Ethics committee name [28] 2048 0
Monash Medical Centre.
Ethics committee address [28] 2048 0
Ethics committee country [28] 2048 0
Australia
Date submitted for ethics approval [28] 2048 0
Approval date [28] 2048 0
Ethics approval number [28] 2048 0
Ethics committee name [29] 2049 0
Royal Perth Hospital.
Ethics committee address [29] 2049 0
Ethics committee country [29] 2049 0
Australia
Date submitted for ethics approval [29] 2049 0
Approval date [29] 2049 0
Ethics approval number [29] 2049 0
Ethics committee name [30] 2050 0
Fremantle Hospital.
Ethics committee address [30] 2050 0
Ethics committee country [30] 2050 0
Australia
Date submitted for ethics approval [30] 2050 0
Approval date [30] 2050 0
Ethics approval number [30] 2050 0
Ethics committee name [31] 2051 0
Christchurch Hospital.
Ethics committee address [31] 2051 0
Ethics committee country [31] 2051 0
New Zealand
Date submitted for ethics approval [31] 2051 0
Approval date [31] 2051 0
Ethics approval number [31] 2051 0
Ethics committee name [32] 2052 0
Waikato Hospital
Ethics committee address [32] 2052 0
Ethics committee country [32] 2052 0
New Zealand
Date submitted for ethics approval [32] 2052 0
Approval date [32] 2052 0
Ethics approval number [32] 2052 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35819 0
Address 35819 0
Country 35819 0
Phone 35819 0
Fax 35819 0
Email 35819 0
Contact person for public queries
Name 9774 0
Allison Humphries
Address 9774 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9774 0
Australia
Phone 9774 0
+61 2 93850900
Fax 9774 0
+61 2 93850910
Email 9774 0
ahumphries@nchecr.unsw.edu.au
Contact person for scientific queries
Name 702 0
Associate Professor Sean Emery
Address 702 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 702 0
Australia
Phone 702 0
+61 2 93850900
Fax 702 0
+61 2 93850910
Email 702 0
semery@nchecr.unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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