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


This study has been completed.

Detailesd 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.

Primary Outcome Measures

  • virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart

Secondary Outcome Measures

  • 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 ]
  • glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART [ Time Frame: Week 48 and 96 ]

Publications
The influence of HLA supertype on thymidine analogue associated with low peripheral fat in HIV.
Cordery DV, Martin A, Amin J, Kelleher AD, Emery S, Cooper DA; STEAL study group.
AIDS. 2012 Nov 28;26(18):2337-44. doi: 10.1097/QAD.0b013e32835ab213.
PMID: 23032422 [PubMed – in process]

Changes in bone turnover and bone loss in HIV-infected patients changing treatment to tenofovir-emtricitabine or abacavir-lamivudine.
Haskelberg H, Hoy JF, Amin J, Ebeling PR, Emery S, Carr A, STEAL Study Group.
PLoS One. 2012;7(6):e38377. doi: 10.1371/journal.pone.0038377. Epub 2012 Jun 15.
PMID: 22719882 [PubMed – indexed for MEDLINE] Free PMC Article

Predictors of Limb Fat Gain in HIV Positive Patients Following a Change to Tenofovir-Emtricitabine or Abacavir-Lamivudine.
Martin A, Amin J, Emery S, Baker D, Carr A, Cooper DA, Bloch M.
PLoS One. 2011;6(10):e26885. Epub 2011 Oct 28.
PMID: 22046394 [PubMed – as supplied by publisher]

Abacavir does not affect circulating levels of inflammatory or coagulopathic biomarkers in suppressed HIV: a randomized clinical trial.
Martin A, Amin J, Cooper DA, Carr A, Kelleher AD, Bloch M, Baker D, Woolley I, Emery S; STEAL study group.
AIDS. 2010 Nov 13;24(17):2657-63.

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