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    Summary
    EudraCT Number:2008-006439-12
    Sponsor's Protocol Code Number:INSIGHT001:STARTDAIDSID#10619
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedIreland - HPRA
    A.2EudraCT number2008-006439-12
    A.3Full title of the trial
    Strategic Timing of AntiRetroviral Treatment (START)
    A.3.2Name or abbreviated title of the trial where available
    START
    A.4.1Sponsor's protocol code numberINSIGHT001:STARTDAIDSID#10619
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegents of the University of Minnesota
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Subcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV Infection
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the benefit of early ART(as published in the definitive phase of the study) compared to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS*( AIDS with asterisk include most traditional OI but exclude non-fatal esophageal candidiasis and chronic Herpes simplex)nonAIDS, or death from any cause is maintained, increased or reduced.
    Secondary Objectives: A)To compare early ART to deferred ART for the following components of the primary composite outcome:AIDS*or death from AIDS,SNA or death not attributable to AIDS, CVD(myocardial infarction,stroke,coronary revascularisation)or death due to,CVD, Cancer(AIDS and SNA malignancy,excluding basal and squamous cell,skin cancers),All-cause mortality,Tuberculosis,Serious bacterial infections.B)Compare early ART to deferred ART for other clinical outcomes:ESRD(dialysis,renal transplantation),ARLD,SNA malignancy,including basal and squamous cell skin cancers,AIDS, Unscheduled hospitalisations.
    E.2.2Secondary objectives of the trial
    C) To compare early ART with deferred ART for the primary composite outcome and other major clinical outcomes in subgroups defined by the following characteristics measured at baseline: Age, Gender, Race/ethnicity, Presence and levels of risk factors, including risk scores which are based on several risk factors, for serious non-AIDS and AIDS conditions in addition to age, gender and race/ethnicity (e.g., smoking, estimated GFR (eGFR), hepatitis coinfection, diabetes mellitus, estimated CVD risk, lipids, blood pressure, presence of resting ECG abnormalities), Baseline CD4+ cell count, Baseline CD8+ cell count, Baseline HIV RNA level, Baseline IL-6 level, Baseline D-dimer level, Duration of HIV infection, including those recently infected and those who are slow/non-progressors. Viral characteristics, including subtype, and evidence of transmitted drug resistance, Host genetic traits, Geographic region, High versus low/moderate income countries, Calendar date of enrollment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent, HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry,
    Age > 18 years (when 4000 participants are enrolled age criteria will change to greater than/equal to 35 years), Karnofsky performance score ≥ 80 (an indication that the participant can perform normal activities), Perceived life expectancy of at least 6 months, For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed, Two CD4+ cell
    counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization
    E.4Principal exclusion criteria
    Any previous use of ART or IL-2, Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection); Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever at randomizaton; Cardiovascular event (myocardial infarction,
    angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization; Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization; Dialysis within 6 months before randomization; Diagnosis of decompensated liver disease before randomization; Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness; Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential).
    E.5 End points
    E.5.1Primary end point(s)
    i) AIDS* or death from AIDS: Opportunistic events consistent with the 1993 CDC expanded surveillance definition plus additional events associated with immunosuppression in the patient population targeted for enrollment. Esophageal candidiasis and chronic Herpes simplex infection will be counted as primary endpoints only if they result in death.
    ii) Non-AIDS: CVD: myocardial infarction, stroke, coronary revascularisation; End-stage renal disease: initiation of dialysis, renal transplantation; Decompensated liver disease; Non-AIDS-defining cancers, excluding basal and squamous cell skin cancers. Basal and squamous cell skin cancer will be counted as a primary endpoint only if they result in death. iii) Death not attributable to AIDS, including death of unknown cause. The primary outcome of START and each of the major components of the primary outcome will be evaluated as the time to the first occurrence of an event above.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study is planned to complete enrolment in late 2013/early 2014 and follow-up will continue through 2021.
    E.5.2Secondary end point(s)
    Separate components of the composite outcome; AIDS* or death from AIDS; Non-AIDS or death not attributable to AIDS; CVD (myocardial infarction, stroke, coronary revascularisation) or death due to CVD; Cancer (AIDS and non-AIDS
    malignancy, excluding basal and squamous cell skin cancers); All-cause mortality; Tuberculosis; Serious bacterial infections; ESRD (initiation of dialysis, renal transplantation); Decompensated liver disease; Non-AIDS malignancy,
    including basal and squamous cell skin cancers; AIDS; Unscheduled hospitalizations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study is planned to complete enrolment in late 2013/early 2014 and follow-up will continue through 2021.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    strategy study (see E.2)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Early initiation of ART versus deferred initiation of ART
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will proceed in 2 phases:1) pilot phase (900 participants, 1year, 70 sites); & 2) definitive phase (estimated 4000 participants, up to 6 years). Pilot phase was completed in Oct 2010 & the study is proceeding with the 2nd phase. A protocol defined re-estimation was completed in late 2012, resulting in an increase in the sample size from 4000 to 4600. Participants will be followed to a common closing date of 31 December 2021.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4590
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    HIV positive individuals
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 4600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    It is anticipated that at the end of START a closeout period of approximately 6 months will be required to complete all data collection.During this time period, ART from the INSIGHT Central ART Repository may be used, & sites will be expected to transition all participants to other ART sources. During this time period adverse
    events will continue to be reported. Stopping ART is not recommended. All participating sites must have a plan for providing ART to participants at the end of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-31
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