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.
Sponsor:
Kirby Institute
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00192634
First received: September 13, 2005
Last updated: May 24, 2011
Last verified: May 2011
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Lamivudine
Abacavir
Emtricitabine
Tenofovir
Abacavir sulfate
Tenofovir Disoproxil Fumarate
Truvada
U.S. FDA Resources
Further study details as provided by Kirby Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
- glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART. [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: Yes ]
| Enrollment: | 357 |
| Study Start Date: | December 2005 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Abacavir 600mg/Lamivudine 300mg
|
Drug: Abacavir 600mg - Lamivudine 300mg
1 tablet once daily for 96 weeks
Other Name: Kivexa
|
|
Active Comparator: 2
Tenofovir 300mg/emtricitabine 200mg
|
Drug: Emtricitabine 200mg - Tenofovir 300mg
1 tablet once daily for 96 weeks
Other Name: Truvada
|
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:
- tenofovir (TDF) 300mg + emtricitabine (FTC) 200mg OR
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192634
Locations
| Australia, New South Wales | |
| Holdsworth House General Practice - Byron Bay | |
| Byron Bay, New South Wales, Australia, 2481 | |
| Lismore Sexual Health Clinic - Northen Rivers Area Health Service | |
| Lismore, New South Wales, Australia, 2480 | |
| John Hunter Hospital | |
| Newcastle, New South Wales, Australia, 2304 | |
| St. Vincent's Hospital | |
| Sydney, New South Wales, Australia, 2010 | |
| Westmead Hospital | |
| Sydney, New South Wales, Australia, 2145 | |
| Holdsworth House General Practice | |
| Sydney, New South Wales, Australia, 2010 | |
| Clinic 16, Royal North Shore Hospital | |
| Sydney, New South Wales, Australia, 2065 | |
| Burwood Road Practice | |
| Sydney, New South Wales, Australia, 2134 | |
| Taylor Square Private Clinic | |
| Sydney, New South Wales, Australia, 2010 | |
| Prince of Wales Hospital | |
| Sydney, New South Wales, Australia, 2031 | |
| Albion Street Centre | |
| Sydney, New South Wales, Australia, 2010 | |
| 407 Doctors | |
| Sydney, New South Wales, Australia, 2010 | |
| Liverpool Health Service | |
| Sydney, New South Wales, Australia, 2170 | |
| Australia, Queensland | |
| Gladstone Road Medical Centre | |
| Brisbane, Queensland, Australia, 4101 | |
| Royal Brisbane and Women's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| QLD Health - AIDS Medical Unit | |
| Brisbane, Queensland, Australia, 4002 | |
| Doll's House Clinic - Cairns Base Hospital | |
| Cairns, Queensland, Australia, 4870 | |
| Gold Coast Sexual Health Clinic | |
| Miami, Queensland, Australia, 4220 | |
| Clinic 87, Nambour Hospital | |
| Nambour, Queensland, Australia, 4560 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Flinders Medical Centre | |
| Adelaide, South Australia, Australia, 5042 | |
| The Care and Prevention Programme - Adelaide University | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Melbourne Sexual Health Centre | |
| Melbourne, Victoria, Australia, 3053 | |
| Carlton Clinic | |
| Melbourne, Victoria, Australia, 3053 | |
| The Alfred Hospital | |
| Melbourne, Victoria, Australia, 3004 | |
| Royal Melbourne Hospital | |
| Melbourne, Victoria, Australia, 3403 | |
| Prahran Market Clinic | |
| Melbourne, Victoria, Australia, 3141 | |
| The Centre Clinic | |
| Melbourne, Victoria, Australia, 3182 | |
| Monash Medical Centre | |
| Melbourne, Victoria, Australia, 3168 | |
| Australia, Western Australia | |
| Fremantle Hospital | |
| Fremantle, Western Australia, Australia, 6160 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
Sponsors and Collaborators
Kirby Institute
Investigators
| Principal Investigator: | Andrew Carr, MD FRACP FRCPA | Kirby Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof Sean Emery, The National Centre in HIV Epidemiology and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00192634 History of Changes |
| Other Study ID Numbers: | STEAL, ACTRN012605000505606 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 24, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Kirby Institute:
|
HIV Antiretroviral therapy nucleoside analogue reverse transcriptase fixed dose combination Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine Tenofovir Tenofovir disoproxil |
Abacavir Dideoxynucleosides Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on May 19, 2013