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Sponsored by: |
The National Centre in HIV Epidemiology and Clinical Research |
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Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00192634 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Emtricitabine 200mg – Tenofovir 300mg Drug: Abacavir 600mg – Lamivudine 300mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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. |
Estimated Enrollment: | 350 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | July 2008 |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
creatinine clearance < 50 mL/min (estimated by the Cockcroft-Gault equation)18,19
Contact: Allison Humphries, MSc GradDipPH | +61 2 9385 0900 | ahumphries@nchecr.unsw.edu.au |
Contact: Sean Emery, PhD | +61 2 9385 0900 | semery@nchecr.unsw.edu.au |
Australia, New South Wales | |
Lismore Sexual Health Clinic - Northen Rivers Area Health Service | Recruiting |
Lismore, New South Wales, Australia, 2480 | |
Contact: Denni Pearson +61 (02) 6620-2980 dennip@nrahs.nsw.gov.au | |
Principal Investigator: David Smith | |
John Hunter Hospital | Recruiting |
Newcastle, New South Wales, Australia, 2304 | |
Contact: Leah Carrall +61 2 4921 4766 Leah.Carrall@hnehealth.nsw.gov.au | |
Contact: Pauline Dobson +61 2 4921 4766 Pauline.Dobson@hnehealth.nsw.gov.au | |
Principal Investigator: Michael Boyle | |
Clinic 16, Royal North Shore Hospital | Recruiting |
Sydney, New South Wales, Australia, 2065 | |
Contact: James Baber +61 (02) 9926-7414 JBaber@nsccahs.health.nsw.gov.au | |
Principal Investigator: Linda Dayan | |
St. Vincent's Hospital | Recruiting |
Sydney, New South Wales, Australia, 2010 | |
Contact: Richard Norris +61 (02) 8382-2435 rnorris@stvincents.com.au | |
Principal Investigator: Andrew Carr, MD FRACP FRCPA | |
Burwood Road Practice | Recruiting |
Sydney, New South Wales, Australia, 2134 | |
Contact: Jeff Hudson +61 (02) 9745-2755 burwood8@bigpond.net.au | |
Principal Investigator: Nicholas Doong | |
Holdsworth House General Practice | Recruiting |
Sydney, New South Wales, Australia, 2010 | |
Contact: Shikha Agrawal +61 (02) 9331-7822 trials@holdsworthhouse.com.au | |
Principal Investigator: Mark Bloch | |
Holdsworth House General Practice - Byron Bay | Recruiting |
Byron Bay, New South Wales, Australia, 2481 | |
Contact: Debra Hayhoe +61 (02) 6680-7211 dhayhoe@holdsworthhouse.com.au | |
Principal Investigator: Janet Knox | |
Westmead Hospital | Recruiting |
Sydney, New South Wales, Australia, 2145 | |
Contact: Margaret Piper +61 (02) 9845-6251 margaretp@icpmr.wsahs.nsw.gov.au | |
Principal Investigator: Dominic Dwyer | |
Taylor Square Private Clinic | Recruiting |
Sydney, New South Wales, Australia, 2010 | |
Contact: Sophie Dinning +61 (02) 9331-6151 sdinning@tspc.com.au | |
Contact: Robyn Richardson +61 (02) 9331-6151 robynr@tspc.com.au | |
Principal Investigator: Robert Finlayson | |
Prince of Wales Hospital | Recruiting |
Sydney, New South Wales, Australia, 2031 | |
Contact: Suzanne Ryan +61 (02) 9382-3408 ryans@sesahs.nsw.gov.au | |
Principal Investigator: Jeffrey Post | |
Albion Street Centre | Recruiting |
Sydney, New South Wales, Australia, 2010 | |
Contact: Jason Gao +61 (02) 9332-9705 Jason.Gao@sesiahs.health.nsw.gov.au | |
Principal Investigator: Don Smith | |
407 Doctors | Recruiting |
Sydney, New South Wales, Australia, 2010 | |
Contact: Robyn Vale +61 (02) 9332-2531 robynv@407.com.au | |
Principal Investigator: David Baker | |
Liverpool Health Service | Recruiting |
Sydney, New South Wales, Australia, 2170 | |
Contact: Helen Best +61 (02) 9827-8038 Helen.Best@swsahs.nsw.gov.au | |
Principal Investigator: John Quin, MD | |
Australia, Queensland | |
Clinic 87, Nambour Hospital | Recruiting |
Nambour, Queensland, Australia, 4560 | |
Contact: Colleen Shields +61 (07) 5476-2489 Colleen_shields@health.qld.gov.au | |
Principal Investigator: David Sowden, MB BS RACOG FRACP FRCPA | |
Doll's House Clinic - Cairns Base Hospital | Recruiting |
Cairns, Queensland, Australia, 4870 | |
Contact: Joanne Leamy +61 (07) 4050-6205 Joanne_Leamy@health.qld.gov.au | |
Principal Investigator: Darren Russell | |
Gold Coast Sexual Health Clinic | Recruiting |
Miami, Queensland, Australia, 4220 | |
Contact: Denise Lester +61 (07) 5576 9033 DeniseJ_Lester@health.qld.gov.au | |
Contact: Tammy Schmidt + 61 (07) 5576 9033 tammy_schmidt@health.qld.gov.au | |
Principal Investigator: John Chuah | |
QLD Health - AIDS Medical Unit | Recruiting |
Brisbane, Queensland, Australia, 4002 | |
Contact: Paul Negus +61 (07) 3837-5622 paul_negus@health.qld.gov.au. | |
Principal Investigator: Mark Kelly | |
Royal Brisbane and Women's Hospital | Recruiting |
Brisbane, Queensland, Australia, 4029 | |
Contact: Janelle Zillmann +61 (07) 3636-7324 Janelle_Zillmann@health.qld.gov.au | |
Principal Investigator: Anthony Allworth | |
Gladstone Road Medical Centre | Recruiting |
Brisbane, Queensland, Australia, 4101 | |
Contact: David Youds +61 (07) 3844-9599 d.youds123@optusnet.com.au | |
Principal Investigator: David Orth | |
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Lyndal Daly +61 (08) 8222-5635 ldaly@mail.rah.sa.gov.au | |
Principal Investigator: David Shaw | |
Flinders Medical Centre | Recruiting |
Adelaide, South Australia, Australia, 5042 | |
Contact: Robyn Gilligan +61 8 8204-4292 robyn.gilligan@fmc.sa.gov.au | |
Principal Investigator: Mark Boyd | |
The Care and Prevention Programme - Adelaide University | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Michael Curry +61 8 8231-4026 Michael@careandprevention.org | |
Principal Investigator: Gary Rogers, MD | |
Australia, Victoria | |
Melbourne Sexual Health Centre | Recruiting |
Melbourne, Victoria, Australia, 3053 | |
Contact: Helen Kent +61 (03) 9347-4144 researchunit@mshc.org.au | |
Contact: Julie Silvers +61 (03) 9347-4144 jsilvers@mshc.org.au | |
Principal Investigator: Tim Read | |
Carlton Clinic | Recruiting |
Melbourne, Victoria, Australia, 3053 | |
Contact: Kaye Lowe +61 (03) 9347-9422 kaye.lowe@maynemc.com | |
Principal Investigator: Jonathan Anderson | |
The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Christine Alverez +61 (03) 9276-6908 clinresearch@alfred.org.au | |
Principal Investigator: Jenny Hoy | |
Royal Melbourne Hospital | Recruiting |
Melbourne, Victoria, Australia, 3403 | |
Contact: Janine Roney +61 (03) 9342-7212 janine.roney@mh.org.au | |
Principal Investigator: Alan Street | |
Prahran Market Clinic | Recruiting |
Melbourne, Victoria, Australia, 3141 | |
Contact: Helen Wood +61 (03) 9826-4500 hpwood@optusnet.com.au | |
Principal Investigator: Norman Roth | |
The Centre Clinic | Recruiting |
Melbourne, Victoria, Australia, 3182 | |
Contact: Helen Wood +61 (3 9525) 5866 hpwood@optusnet.com.au | |
Principal Investigator: Nicholas Medland | |
Monash Medical Centre | Recruiting |
Melbourne, Victoria, Australia, 3168 | |
Contact: Pauline Galt +61 (03) 9594-3048 pauline.galt@southernhealth.org.au | |
Principal Investigator: Ian Woolley | |
Australia, Western Australia | |
Royal Perth Hospital | Recruiting |
Perth, Western Australia, Australia, 6000 | |
Contact: Claire Forsdyke +61 (08) 9224-3427 claire.forsdyke@health.wa.gov.au | |
Principal Investigator: David Nolan | |
Fremantle Hospital | Recruiting |
Fremantle, Western Australia, Australia, 6160 | |
Contact: Jacqueline Kerth +61 (08) 9431-2182 jacqueline.kerth@health.wa.gov.au | |
Principal Investigator: John Dyer |
Principal Investigator: | Andrew Carr, MD FRACP FRCPA | The National Centre in HIV Epidemiology and Clinical Research |
Study ID Numbers: | STEAL, ACTRN012605000505606 |
Study First Received: | September 13, 2005 |
Last Updated: | June 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00192634 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
HIV Antiretroviral therapy nucleoside analogue reverse transcriptase fixed dose combination Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Tenofovir Lamivudine Abacavir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |