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

May 24, 2011 updated by: Kirby Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Byron Bay, New South Wales, Australia, 2481
        • Holdsworth House General Practice - Byron Bay
      • Lismore, New South Wales, Australia, 2480
        • Lismore Sexual Health Clinic - Northen Rivers Area Health Service
      • Newcastle, New South Wales, Australia, 2304
        • John Hunter Hospital
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital
      • Sydney, New South Wales, Australia, 2010
        • St. Vincent's Hospital
      • Sydney, New South Wales, Australia, 2010
        • 407 Doctors
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House General Practice
      • Sydney, New South Wales, Australia, 2010
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Health Service
      • Sydney, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2010
        • Albion Street Centre
      • Sydney, New South Wales, Australia, 2065
        • Clinic 16, Royal North Shore Hospital
      • Sydney, New South Wales, Australia, 2134
        • Burwood Road Practice
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4101
        • Gladstone Road Medical Centre
      • Brisbane, Queensland, Australia, 4002
        • QLD Health - AIDS Medical Unit
      • Cairns, Queensland, Australia, 4870
        • Doll's House Clinic - Cairns Base Hospital
      • Miami, Queensland, Australia, 4220
        • Gold Coast Sexual Health Clinic
      • Nambour, Queensland, Australia, 4560
        • Clinic 87, Nambour Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Adelaide, South Australia, Australia, 5000
        • The Care and Prevention Programme - Adelaide University
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3053
        • Melbourne Sexual Health Centre
      • Melbourne, Victoria, Australia, 3141
        • Prahran Market Clinic
      • Melbourne, Victoria, Australia, 3053
        • Carlton Clinic
      • Melbourne, Victoria, Australia, 3182
        • The Centre Clinic
      • Melbourne, Victoria, Australia, 3403
        • Royal Melbourne Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Abacavir 600mg/Lamivudine 300mg
Drug: Abacavir 600mg - Lamivudine 300mg
1 tablet once daily for 96 weeks
Other Names:
  • Kivexa
Active Comparator: 2
Tenofovir 300mg/emtricitabine 200mg
Drug: Emtricitabine 200mg - Tenofovir 300mg
1 tablet once daily for 96 weeks
Other Names:
  • Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Week 48 and 96
Week 48 and 96
glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART.
Time Frame: Week 48 and 96
Week 48 and 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Andrew Carr, MD FRACP FRCPA, Kirby Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 25, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEAL
  • ACTRN012605000505606

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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