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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00192634
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
Kirby Institute

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 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 or disease Intervention/treatment Phase
HIV Infections Drug: Emtricitabine 200mg - Tenofovir 300mg Drug: Abacavir 600mg - Lamivudine 300mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART. [ Time Frame: Week 48 and 96 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192634


Locations
Show Show 31 study locations
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Andrew Carr, MD FRACP FRCPA Kirby Institute
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Sean Emery, The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier: NCT00192634    
Other Study ID Numbers: STEAL
ACTRN012605000505606
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: May 2011
Keywords provided by Kirby Institute:
HIV
Antiretroviral therapy
nucleoside analogue reverse transcriptase
fixed dose combination
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Lamivudine
Emtricitabine
Abacavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents