Trial document




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  DRKS00000374

Trial Description

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Title

Strategic Timing of AntiRetroviral Treatment

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Trial Acronym

START

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URL of the Trial

http://insight.ccbr.umn.edu/start/

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Brief Summary in Lay Language

This study is being done to find out the best time to start taking HIV medicines. The study will look at whether starting HIV medicines early may help you stay healthy longer than waiting for your CD4+ to drop to the point at which most guidelines recommend you start treatment.
In Amendment No. 2 for Germany the inclusion criterion for age is modified following the enrollment of 4000 participants to 4600.
The protocol states the the participants 18 and older are eligible. This inclusion criterion is changed to 35 years or older.
START is an endpoint-driven trial that needs to be completed in a timely and cost-effective manner; preferential inclusion of older persons who are expected to have a higher rate of the primary endpoint will help to achieve this objective.

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Brief Summary in Scientific Language

The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 infected persons who are antiretroviral naïve with a CD4+ count greater than 500 cells/mm3.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000374
  •   2010/09/22
  •   2009/03/20
  •   no
  •   Approved
  •   09-102, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   2008-006439-12 
  •   NCT00867048  (ClinicalTrials.gov)
  •   4035309 
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Health Condition or Problem studied

  •   HIV-Infection
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Interventions/Observational Groups

  •   Patients in the EARLY Group will
    take HIV medicines immediately and will
    continue taking HIV medicines to keep the
    amount of virus in your blood as low as
    possible.
  •   Patients in the DEFERRED Group and
    remain well, will NOT take HIV
    medicines while in the study until their
    CD4+ cell count drops to 350/mm³.
    At that time, the patient and his healthcare
    provider will choose HIV medicines that
    he will begin to take.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality

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Secondary Outcome

•Components of the composite primary outcome measure [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

•Specific non-AIDS diagnoses [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

•Adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

•Hospitalization, health-care utilization, quality of life [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

•HIV drug resistance and transmission risk behavior [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

•Change in neurocognitive function (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

•Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants) [ Time Frame: Blood taken at study entry and stored in a central repository indefinitely ] [ Designated as safety issue: No ]

•Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites) [ Time Frame: Before randomization into START ] [ Designated as safety issue: No ]

•Large and small artery elasticity (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

•Rate of lung function decline (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

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Countries of Recruitment

  •   Germany
  •   United States
  •   Argentina
  •   Australia
  •   Belgium
  •   Brazil
  •   Chile
  •   Denmark
  •   Finland
  •   France
  •   Greece
  •   Israel
  •   Italy
  •   Mali
  •   Morocco
  •   Peru
  •   Poland
  •   Singapore
  •   South Africa
  •   Spain
  •   Switzerland
  •   Thailand
  •   United Kingdom
  •   Uganda
  •   Mexico
  •   Luxembourg
  •   India
  •   Ireland
  •   Malaysia
  •   Sweden
  •   Nigeria
  •   Norway
  •   Portugal
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/03/15
  •   4600
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   99   Years
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Additional Inclusion Criteria

· Signed informed consent· HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed[1] ELISA test; and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.· Age >= 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 consecutive CD4+ cell counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization

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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 · 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· History of decompensated liver disease· 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)

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Addresses

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    • University of Minnesota Clinical and Translational Science Institute
    • 717 Delaware Street SE
    • MN 55414  Minneapolis
    • United States
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    • Universitätsklinik Köln Medizinische Klinik I Infektiologie
    • Mr.  Professsor  Gerd  Fätkenheuer  
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Universitätsklinik Köln
    • Mr.  Prof.  Gerd  Fätkenheuer 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Projektträger im Deutschen Zentrum für Luft- und Raumfahrt e.V. Gesundheitsforschung
    • Heinrich-Konen-Str.1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2019/09/22
  •   175
  •   4625
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Trial Publications, Results and other Documents

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