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ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)
Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus (HIV) focused on measuring Human Immunodeficiency Virus (HIV)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6 months from date of randomisation. Aged > 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate). Antiretroviral treatment naïve. Qualifying plasma HIV RNA > 2,000 copies/mL and a CD4+ T cell count of ≥ 50 cells/µL. No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing). Calculated creatinine clearance (CLCr) greater than or equal to 70 mL/min (Cockcroft-Gault formula). Able to provide written informed consent. Exclusion Criteria: The following laboratory variables, absolute neutrophil count (ANC) < 750 cells/µL haemoglobin < 8.0 g/dL platelet count < 50,000 cells/µL serum AST, ALT > 5 x upper limit of normal (ULN) serum bilirubin > 1.5 x ULN Pregnant or nursing mothers. Current use of human growth hormone, testosterone or other anabolic steroid. Current use of any prohibited medications as described in product specific information. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial. Patients unlikely to be able to remain in follow-up for the protocol-defined period. Patients with known renal insufficiency. Patients with obstructive liver disease. Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days). History of acute or chronic pancreatitis. Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    1

    2

    3

    Arm Description

    Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin efavirenz)

    Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)

    Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)

    Outcomes

    Primary Outcome Measures

    Time-weighted Mean Change From Baseline Plasma HIV-RNA.

    Secondary Outcome Measures

    Time Weighted Mean Change From Baseline Plasma HIV-RNA

    Full Information

    First Posted
    June 8, 2006
    Last Updated
    September 24, 2019
    Sponsor
    Kirby Institute
    Collaborators
    The University of New South Wales
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00335322
    Brief Title
    ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens
    Official Title
    A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kirby Institute
    Collaborators
    The University of New South Wales

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.
    Detailed Description
    The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-RNA, and safety, of three strategic regimens of initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. (Primary comparisons are regimen I versus II and I versus III as described below). I. tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) + emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC) + zidovudine (ZDV) + abacavir (ABC) Secondary objectives of this study will be to undertake a range of analyses including but not limited to the following, Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL) at week 48 and week 96 between treatment arms. Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400 copies/mL) between treatment arms. Time to virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL (and 400 copies/mL) after confirmed < 50 copies/mL (where time = 0 if patient never achieves plasma virus load < 50 or <400 copies/mL). Mean change from baseline of absolute CD4+ T cell count at weeks 48 and 96 between treatment arms. Time to change in randomly assigned therapy (all reasons individually and on aggregate) between treatment arms. Time to first virologic failure (defined as #3 above) or cessation of randomly assigned antiretroviral therapy. Mean change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between treatment arms. Mean change from baseline in peripheral and central adipose tissue, as measured by CT and DEXA at weeks 48 and 96 between treatment arms. Mean change from baseline in fasting lipid and glycemic parameters at weeks 48 and 96 between treatment arms. Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs, between treatment arms. Comparison of total number of patients with any adverse events (AEs), and the cumulative incidence of AEs, associated with cessation of randomly assigned therapy between treatment arms. Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms. Describe aspects of immune reconstitution disease. Adherence to therapy and associations with virologic outcomes between treatment arms. Comparison of quality of life between treatment arms. Following the result of the scheduled week 48 data analysis, the protocol steering committee amended the study protocol as follows: Patients on Arms I and II will remain on the current study drugs Patients on Arm III may be switched at the physician's discretion to either Arm I or II There will be a protocol amendment to include one extra follow up visit at week 144 for all patients, regardless of treatment arm or current treatment All patients are to be encouraged to stay on the study up to week 144, to maximize follow up on study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus (HIV)
    Keywords
    Human Immunodeficiency Virus (HIV)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    329 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin efavirenz)
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
    Intervention Type
    Drug
    Intervention Name(s)
    Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)
    Intervention Description
    Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
    Intervention Description
    Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food)
    Intervention Type
    Drug
    Intervention Name(s)
    Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
    Intervention Description
    Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd
    Primary Outcome Measure Information:
    Title
    Time-weighted Mean Change From Baseline Plasma HIV-RNA.
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    Time Weighted Mean Change From Baseline Plasma HIV-RNA
    Time Frame
    144 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6 months from date of randomisation. Aged > 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate). Antiretroviral treatment naïve. Qualifying plasma HIV RNA > 2,000 copies/mL and a CD4+ T cell count of ≥ 50 cells/µL. No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing). Calculated creatinine clearance (CLCr) greater than or equal to 70 mL/min (Cockcroft-Gault formula). Able to provide written informed consent. Exclusion Criteria: The following laboratory variables, absolute neutrophil count (ANC) < 750 cells/µL haemoglobin < 8.0 g/dL platelet count < 50,000 cells/µL serum AST, ALT > 5 x upper limit of normal (ULN) serum bilirubin > 1.5 x ULN Pregnant or nursing mothers. Current use of human growth hormone, testosterone or other anabolic steroid. Current use of any prohibited medications as described in product specific information. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial. Patients unlikely to be able to remain in follow-up for the protocol-defined period. Patients with known renal insufficiency. Patients with obstructive liver disease. Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days). History of acute or chronic pancreatitis. Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David A Cooper, AO DSc MD FRACP FRCPA FRCP
    Organizational Affiliation
    Kirby Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20735258
    Citation
    Puls RL, Srasuebkul P, Petoumenos K, Boesecke C, Duncombe C, Belloso WH, Molina JM, Li L, Avihingsanon A, Gazzard B, Cooper DA, Emery S; Altair Study Group. Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Clin Infect Dis. 2010 Oct 1;51(7):855-64. doi: 10.1086/656363.
    Results Reference
    result
    PubMed Identifier
    20146627
    Citation
    Winston A, Duncombe C, Li PC, Gill JM, Kerr SJ, Puls R, Petoumenos K, Taylor-Robinson SD, Emery S, Cooper DA; Altair Study Group. Does choice of combination antiretroviral therapy (cART) alter changes in cerebral function testing after 48 weeks in treatment-naive, HIV-1-infected individuals commencing cART? A randomized, controlled study. Clin Infect Dis. 2010 Mar 15;50(6):920-9. doi: 10.1086/650743. Erratum In: Clin Infect Dis. 2010 Sep 1;51(5):638.
    Results Reference
    result
    PubMed Identifier
    25872747
    Citation
    Berthon-Jones N, Courtney-Vega K, Donaldson A, Haskelberg H, Emery S, Puls R. Assessing site performance in the Altair study, a multinational clinical trial. Trials. 2015 Apr 8;16:138. doi: 10.1186/s13063-015-0653-x.
    Results Reference
    derived
    Links:
    URL
    https://kirby.unsw.edu.au/
    Description
    The Kirby Institute homepage (formerly known as the National Centre in HIV Epidemiology and Clinical Research)

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    ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens

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