AzTrials
AzTrials

HIV InfectionsPhase 4NCT00192634

A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study

A Phase 4 study testing Emtricitabine 200mg - Tenofovir 300mg and Abacavir 600mg - Lamivudine 300mg in people with HIV Infections, run by Kirby Institute at 31 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Emtricitabine 200mg - Tenofovir 300mg and Abacavir 600mg - Lamivudine 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
357 participants
Where
31 sitesAustralia
Study dates
Dec 2005to Aug 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Australia31 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Care and Prevention Programme - Adelaide University

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

  • QLD Health - AIDS Medical Unit

    Brisbane, Queensland, 4002

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Gladstone Road Medical Centre

    Brisbane, Queensland, 4101

  • Holdsworth House General Practice - Byron Bay

    Byron Bay, New South Wales, 2481

  • Doll's House Clinic - Cairns Base Hospital

    Cairns, Queensland, 4870

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Lismore Sexual Health Clinic - Northen Rivers Area Health Service

    Lismore, New South Wales, 2480

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Carlton Clinic

    Melbourne, Victoria, 3053

  • Melbourne Sexual Health Centre

    Melbourne, Victoria, 3053

  • Prahran Market Clinic

    Melbourne, Victoria, 3141

  • Monash Medical Centre

    Melbourne, Victoria, 3168

  • The Centre Clinic

    Melbourne, Victoria, 3182

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3403

  • Gold Coast Sexual Health Clinic

    Miami, Queensland, 4220

  • Clinic 87, Nambour Hospital

    Nambour, Queensland, 4560

  • John Hunter Hospital

    Newcastle, New South Wales, 2304

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • 407 Doctors

    Sydney, New South Wales, 2010

  • Albion Street Centre

    Sydney, New South Wales, 2010

  • Holdsworth House General Practice

    Sydney, New South Wales, 2010

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

  • Taylor Square Private Clinic

    Sydney, New South Wales, 2010

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

  • Clinic 16, Royal North Shore Hospital

    Sydney, New South Wales, 2065

  • Burwood Road Practice

    Sydney, New South Wales, 2134

  • Westmead Hospital

    Sydney, New South Wales, 2145

  • Liverpool Health Service

    Sydney, New South Wales, 2170

Other trials in Australia

About this study

Official title: A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study.

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.

Read the detailed description

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:

  1. tenofovir (TDF) 300mg + emtricitabine (FTC) 200mg OR
  2. 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.

Conditions
HIV Infections
Being tested
Emtricitabine 200mg - Tenofovir 300mg, Abacavir 600mg - Lamivudine 300mg
Keywords
HIV, Antiretroviral therapy, nucleoside analogue reverse transcriptase, fixed dose combination, Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emtricitabine 200mg - Tenofovir 300mgDrug

    Also called Truvada

    1 tablet once daily for 96 weeks

  • Abacavir 600mg - Lamivudine 300mgDrug

    Also called Kivexa

    1 tablet once daily for 96 weeks

Study groups in NCT00192634
Study groupRoleWhat they receive
1Active comparatorAbacavir 600mg/Lamivudine 300mg
Receives: Drug: Abacavir 600mg - Lamivudine 300mg
2Active comparatorTenofovir 300mg/emtricitabine 200mg
Receives: Drug: Emtricitabine 200mg - Tenofovir 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart(Roche Amplicor v1.5, LLD 50 copies/mL)

    Measured: Week 48

Secondary outcomes (2)

  1. 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

    Measured: Week 48 and 96

  2. glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART.

    Measured: Week 48 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00192634
Sponsor's protocol ID
STEAL
Other IDs
ACTRN012605000505606
Status last verified
May 2011
First submitted
13 Sep 2005
Last updated
25 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • http://www.retroconference.org/AbstractSearch/Default.aspx?Conf=18

  • Martin A, Bloch M, Amin J, Baker D, Cooper DA, Emery S, Carr A. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-Lamivudine: a randomized, 96-week trial. Clin Infect Dis. 2009 Nov 15;49(10):1591-601. doi: 10.1086/644769.

    PubMed 19842973

  • Haskelberg H, Pocock N, Amin J, Ebeling PR, Emery S, Carr A; STEAL study investigators; Allworth A. Hip structural parameters over 96 weeks in HIV-infected adults switching treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS One. 2014 Apr 10;9(4):e94858. doi: 10.1371/journal.pone.0094858. eCollection 2014.

    PubMed 24722774

  • Haskelberg H, Cordery DV, Amin J, Kelleher AD, Cooper DA, Emery S; STEAL Study Group. HLA alleles association with changes in bone mineral density in HIV-1-infected adults changing treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS One. 2014 Mar 28;9(3):e93333. doi: 10.1371/journal.pone.0093333. eCollection 2014.

    PubMed 24681993

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Emtricitabine 200mg - Tenofovir 300mg and Abacavir 600mg - Lamivudine 300mg in people with HIV Infections, run by Kirby Institute at 31 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00192634, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in