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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-006439-12
    Sponsor's Protocol Code Number:INSIGHT001:STARTDAIDSID#10619
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-24
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-006439-12
    A.3Full title of the trial
    Strategic Timing of AntiRetroviral Treatment(START)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    START study
    A.3.2Name or abbreviated title of the trial where available
    START
    A.4.1Sponsor's protocol code numberINSIGHT001:STARTDAIDSID#10619
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00867048
    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.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
    E.1.1.1Medical condition in easily understood language
    HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Based on two scientific hypotheses, both which take advantage of the randomized design of START and the extended follow-up through 2021, the primary objective is to determine whether the benefit of early ART as compared to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause is maintained, increased or reduced.
    E.2.2Secondary objectives of the trial
    To compare early ART to deferred ART for the following secondary outcomes: All-cause mortality, ESRD (initiation of dialysis, renal transplantation), Decompensated liver disease, Non-AIDS malignancy, including basal and squamous cell skin cancers, AIDS, Bacterial pneumonia, Adverse events, Hospitalization, Quality of life (through December 2015), Health-care utilization and cost of care (through December 2015), HIV transmission risk behavior (through December 2015), HIV drug resistance, Pulmonary embolism or deep vein thrombosis, New-onset diabetes mellitus, Coronary artery disease requiring drug treatment, Congestive heart failure, Peripheral arterial disease, Change in estimated GFR and development of proteinuria, Blood pressure and blood lipids, ECG abnormalities (through December 2016), Use of blood pressure- or lipid-lowering treatment or aspirin, Fractures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All HIV-positive participants in START are eligible to continue in extended follow-up
    E.4Principal exclusion criteria
    Not applicable
    E.5 End points
    E.5.1Primary end point(s)
    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.Non AIDSCVD: myocardial infarction, stroke, coronary revascularizationESRD: initiation of dialysis, renal
    transplantationDecompensated liver diseaseNon-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.Death not attributable to AIDS, including death of unknown causeThe 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 endpoints will be assessed as part of the extended follow-up. All of these endpoints have been assessed since the beginning of the START trial in 2009; therefore, the two treatment strategies will be compared for the following three calendar periods: 1) from randomization to December 31, 2015; 2) from January 1, 2016 to December 31, 2021; and 3) cumulatively from randomization through 2021
    E.5.2Secondary end point(s)
    Separate components of the composite outcome; all-cause mortality; all AIDS events (including esophageal candidiasis and chronic Herpes simplex); all non-AIDS-defining cancers (including basal and squamous cell skin cancers); bacterial pneumonia; pulmonary embolism; deep vein thrombosis; new-onset diabetes mellitus; coronary artery disease requiring drug treatment; congestive heart failure; peripheral vascular disease; fractures; and adverse events. In addition Quality of Life; health care utilization; health care cost; transmission risk behavior; drug resistance & markers of CVD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be assessed as part of the extended follow-up. All of these endpoints have been assessed since the beginning of the START trial in 2009; therefore, the two treatment strategies will be compared for the following three calendar periods: 1) from randomization to December 31, 2015; 2) from January 1, 2016 to December 31, 2021; and 3) cumulatively from randomization 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 Yes
    E.6.5Efficacy Yes
    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
    Initiated on recent guidelines, now started on therapy vs. immediate therapy
    E.8.2.4Number of treatment arms in the trial2
    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 EEA59
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Chile
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    India
    Ireland
    Israel
    Italy
    Luxembourg
    Malaysia
    Mali
    Mexico
    Morocco
    Nigeria
    Norway
    Peru
    Poland
    Portugal
    Singapore
    South Africa
    Spain
    Sweden
    Switzerland
    Thailand
    Uganda
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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 pos. individuals
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1520
    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)
    All participants will stop receiving ART drugs from the START central repository by 31 Dec 2017 and will continue their treatments from locally supplied medications. The choice of treatment will be made bythe treating clinician and patients. Participants will be on medications widely used across the world, with well-defined safety profiles and
    seen according to each countries standard of care.
    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 Decision2011-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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