Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00192634
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00192634