ANZCTR - Registration

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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

Condition category

Condition code

Infection

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]

Treatment: Drugs

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

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]

Secondary outcome [1]

1. plasma HIV RNA <50 copies/mL

Timepoint [1]

Secondary outcome [2]

2. time to virological failure

Timepoint [2]

Secondary outcome [3]

3. virological resistance in those with virological failure

Timepoint [3]

Secondary outcome [4]

4. all serious adverse events, regardless of causality

Timepoint [4]

Secondary outcome [5]

5. clinical adverse events (all grades and grade 3-4), regardless of causality

Timepoint [5]

Secondary outcome [6]

6. use of concomitant medications for toxicity

Timepoint [6]

Secondary outcome [7]

7. adherence (clinician assessed)

Timepoint [7]

Secondary outcome [8]

8. quality of life (SF-8)

Timepoint [8]

Secondary outcome [9]

9. CD4+ lymphocyte count

Timepoint [9]

Secondary outcome [10]

10. full blood count

Timepoint [10]

Secondary outcome [11]

11. biochemistry

Timepoint [11]

Secondary outcome [12]

12. lipid parameters

Timepoint [12]

Secondary outcome [13]

13. glycaemic parameters

Timepoint [13]

Secondary outcome [14]

14. DEXA parameters

Timepoint [14]

Secondary outcome [15]

15. non-traumatic bone fractures

Timepoint [15]

Secondary outcome [16]

16. resolution of adverse events (e.g. dyslipidaemia, low BMD, diabetes)

Timepoint [16]

Secondary outcome [17]

17. progression to AIDS (Category C)

Timepoint [17]

Secondary outcome [18]

18. death

Timepoint [18]

Secondary outcome [19]

19. discontinuation of any ART component

Timepoint [19]

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?

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 Ã¿Âµmol/L)Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 0.814 x (serum creatinine in Ã¿Âµmol/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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Government body

Name

The National Centre in HIV Epidemiology and Clinical Research

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of New South Wales

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Lismore Sexual Health Clinic.

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

John Hunter Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Royal North Shore Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

Holdsworth House GP

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Ethics committee name [5]

Burwood Road Practice.

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

Ethics approval number [5]

Ethics committee name [6]

St. Vincents Hospital

Ethics committee address [6]

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

Ethics approval number [6]

Ethics committee name [7]

Westmead Hospital.

Ethics committee address [7]

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

Ethics approval number [7]

Ethics committee name [8]

Taylor Square Private Clinic

Ethics committee address [8]

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

Ethics approval number [8]

Ethics committee name [9]

Prince of Wales Hospital

Ethics committee address [9]

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

Approval date [9]

Ethics approval number [9]

Ethics committee name [10]

Albion Street Centre

Ethics committee address [10]

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

Approval date [10]

Ethics approval number [10]

Ethics committee name [11]

407 Doctors

Ethics committee address [11]

Ethics committee country [11]

Australia

Date submitted for ethics approval [11]

Approval date [11]

Ethics approval number [11]

Ethics committee name [12]

Liverpool Health Service.

Ethics committee address [12]

Ethics committee country [12]

Australia

Date submitted for ethics approval [12]

Approval date [12]

Ethics approval number [12]

Ethics committee name [13]

Nambour Hospital.

Ethics committee address [13]

Ethics committee country [13]

Australia

Date submitted for ethics approval [13]

Approval date [13]

Ethics approval number [13]

Ethics committee name [14]

Cairns Base Hospital.

Ethics committee address [14]

Ethics committee country [14]

Australia

Date submitted for ethics approval [14]

Approval date [14]

Ethics approval number [14]

Ethics committee name [15]

Gold Coast Sexual Health Clinic

Ethics committee address [15]

Ethics committee country [15]

Australia

Date submitted for ethics approval [15]

Approval date [15]

Ethics approval number [15]

Ethics committee name [16]

AIDS Medical Unit

Ethics committee address [16]

Ethics committee country [16]

Australia

Date submitted for ethics approval [16]

Approval date [16]

Ethics approval number [16]

Ethics committee name [17]

Royal Brisbane and Women's Hospital.

Ethics committee address [17]

Ethics committee country [17]

Australia

Date submitted for ethics approval [17]

Approval date [17]

Ethics approval number [17]

Ethics committee name [18]

Gladstone Road Medical Centre,

Ethics committee address [18]

Ethics committee country [18]

Australia

Date submitted for ethics approval [18]

Approval date [18]

Ethics approval number [18]

Ethics committee name [19]

Royal Adelaide Hospital.

Ethics committee address [19]

Ethics committee country [19]

Australia

Date submitted for ethics approval [19]

Approval date [19]

Ethics approval number [19]

Ethics committee name [20]

Flinders Medical Centre

Ethics committee address [20]

Ethics committee country [20]

Australia

Date submitted for ethics approval [20]

Approval date [20]

Ethics approval number [20]

Ethics committee name [21]

The Care and Prevention Program, Adelaide University

Ethics committee address [21]

Ethics committee country [21]

Australia

Date submitted for ethics approval [21]

Approval date [21]

Ethics approval number [21]

Ethics committee name [22]

Melbourne Sexual Health Centre.

Ethics committee address [22]

Ethics committee country [22]

Australia

Date submitted for ethics approval [22]

Approval date [22]

Ethics approval number [22]

Ethics committee name [23]

Carlton Clinic.

Ethics committee address [23]

Ethics committee country [23]

Australia

Date submitted for ethics approval [23]

Approval date [23]

Ethics approval number [23]

Ethics committee name [24]

The Alfred Hospital.

Ethics committee address [24]

Ethics committee country [24]

Australia

Date submitted for ethics approval [24]

Approval date [24]

Ethics approval number [24]

Ethics committee name [25]

Royal Melbourne Hospital.

Ethics committee address [25]

Ethics committee country [25]

Australia

Date submitted for ethics approval [25]

Approval date [25]

Ethics approval number [25]

Ethics committee name [26]

Prahran Market Clinic.

Ethics committee address [26]

Ethics committee country [26]

Australia

Date submitted for ethics approval [26]

Approval date [26]

Ethics approval number [26]

Ethics committee name [27]

The Centre Clinic.

Ethics committee address [27]

Ethics committee country [27]

Australia

Date submitted for ethics approval [27]

Approval date [27]

Ethics approval number [27]

Ethics committee name [28]

Monash Medical Centre.

Ethics committee address [28]

Ethics committee country [28]

Australia

Date submitted for ethics approval [28]

Approval date [28]

Ethics approval number [28]

Ethics committee name [29]

Royal Perth Hospital.

Ethics committee address [29]

Ethics committee country [29]

Australia

Date submitted for ethics approval [29]

Approval date [29]

Ethics approval number [29]

Ethics committee name [30]

Fremantle Hospital.

Ethics committee address [30]

Ethics committee country [30]

Australia

Date submitted for ethics approval [30]

Approval date [30]

Ethics approval number [30]

Ethics committee name [31]

Christchurch Hospital.

Ethics committee address [31]

Ethics committee country [31]

New Zealand

Date submitted for ethics approval [31]

Approval date [31]

Ethics approval number [31]

Ethics committee name [32]

Waikato Hospital

Ethics committee address [32]

Ethics committee country [32]

New Zealand

Date submitted for ethics approval [32]

Approval date [32]

Ethics approval number [32]

Summary

Brief summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Allison Humphries

Address

National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 93850900

Fax

+61 2 93850910

[email protected]

Contact person for scientific queries

Name

Associate Professor Sean Emery

Address

National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 93850900

Fax

+61 2 93850910

[email protected]

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically