Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00192634




Registration number
NCT00192634
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
25/05/2011

Titles & IDs
Public title
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study
Scientific title
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study.
Secondary ID [1] 0 0
ACTRN012605000505606
Secondary ID [2] 0 0
STEAL
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Emtricitabine 200mg - Tenofovir 300mg
Treatment: Drugs - Abacavir 600mg - Lamivudine 300mg

Active comparator: 1 - Abacavir 600mg/Lamivudine 300mg

Active comparator: 2 - Tenofovir 300mg/emtricitabine 200mg


Treatment: Drugs: Emtricitabine 200mg - Tenofovir 300mg
1 tablet once daily for 96 weeks

Treatment: Drugs: Abacavir 600mg - Lamivudine 300mg
1 tablet once daily for 96 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart(Roche Amplicor v1.5, LLD 50 copies/mL)
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 48 and 96
Secondary outcome [2] 0 0
glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART.
Timepoint [2] 0 0
Week 48 and 96

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
357
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House General Practice - Byron Bay - Byron Bay
Recruitment hospital [2] 0 0
Lismore Sexual Health Clinic - Northen Rivers Area Health Service - Lismore
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [4] 0 0
407 Doctors - Sydney
Recruitment hospital [5] 0 0
Albion Street Centre - Sydney
Recruitment hospital [6] 0 0
Holdsworth House General Practice - Sydney
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [8] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [9] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [10] 0 0
Clinic 16, Royal North Shore Hospital - Sydney
Recruitment hospital [11] 0 0
Burwood Road Practice - Sydney
Recruitment hospital [12] 0 0
Westmead Hospital - Sydney
Recruitment hospital [13] 0 0
Liverpool Health Service - Sydney
Recruitment hospital [14] 0 0
QLD Health - AIDS Medical Unit - Brisbane
Recruitment hospital [15] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [16] 0 0
Gladstone Road Medical Centre - Brisbane
Recruitment hospital [17] 0 0
Doll's House Clinic - Cairns Base Hospital - Cairns
Recruitment hospital [18] 0 0
Gold Coast Sexual Health Clinic - Miami
Recruitment hospital [19] 0 0
Clinic 87, Nambour Hospital - Nambour
Recruitment hospital [20] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [21] 0 0
The Care and Prevention Programme - Adelaide University - Adelaide
Recruitment hospital [22] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [23] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [24] 0 0
Carlton Clinic - Melbourne
Recruitment hospital [25] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment hospital [26] 0 0
Prahran Market Clinic - Melbourne
Recruitment hospital [27] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [28] 0 0
The Centre Clinic - Melbourne
Recruitment hospital [29] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [30] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [31] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2481 - Byron Bay
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2304 - Newcastle
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2031 - Sydney
Recruitment postcode(s) [6] 0 0
2065 - Sydney
Recruitment postcode(s) [7] 0 0
2134 - Sydney
Recruitment postcode(s) [8] 0 0
2145 - Sydney
Recruitment postcode(s) [9] 0 0
2170 - Sydney
Recruitment postcode(s) [10] 0 0
4002 - Brisbane
Recruitment postcode(s) [11] 0 0
4029 - Brisbane
Recruitment postcode(s) [12] 0 0
4101 - Brisbane
Recruitment postcode(s) [13] 0 0
4870 - Cairns
Recruitment postcode(s) [14] 0 0
4220 - Miami
Recruitment postcode(s) [15] 0 0
4560 - Nambour
Recruitment postcode(s) [16] 0 0
5000 - Adelaide
Recruitment postcode(s) [17] 0 0
5042 - Adelaide
Recruitment postcode(s) [18] 0 0
3004 - Melbourne
Recruitment postcode(s) [19] 0 0
3053 - Melbourne
Recruitment postcode(s) [20] 0 0
3141 - Melbourne
Recruitment postcode(s) [21] 0 0
3168 - Melbourne
Recruitment postcode(s) [22] 0 0
3182 - Melbourne
Recruitment postcode(s) [23] 0 0
3403 - Melbourne
Recruitment postcode(s) [24] 0 0
6160 - Fremantle
Recruitment postcode(s) [25] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andrew Carr, MD FRACP FRCPA
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


Results not provided in https://clinicaltrials.gov/study/NCT00192634