Status:
COMPLETED
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study
Lead Sponsor:
Kirby Institute
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00192634
Start Date
December 1 2005
End Date
August 1 2008
Last Update
May 25 2011
Active Locations (31)
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1
Holdsworth House General Practice - Byron Bay
Byron Bay, New South Wales, Australia, 2481
2
Lismore Sexual Health Clinic - Northen Rivers Area Health Service
Lismore, New South Wales, Australia, 2480
3
John Hunter Hospital
Newcastle, New South Wales, Australia, 2304
4
407 Doctors
Sydney, New South Wales, Australia, 2010