Trial document




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  DRKS00000473

Trial Description

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Title

An open label, randomized pilot study to evaluate diagnostic treatment interruption in HIV-positive children under a stable antiretroviral therapy in order to save medication and reduce possible side effects.

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Trial Acronym

DARE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

According to current international guidelines antiretroviral therapy in HIV-infected infants starts independent from clinical signs, virological or immunological parameters due to the fast desease progression. This results in a lifelong antiretroviral therapy.
On the other hand there is a high risk for developing (longterm) adverse effects, resistances and a limited number of pediatric antiretroviral formulations. The aim of this trial is to re-evaluate therapy indication and the establishment of therapeutic treatment interrumptions after infancy.

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Brief Summary in Scientific Language


The aim of this study is to re-evaluate the indication of ART in perinatally HIV-infected children in CDC class N1 and A1 under stable and suppressive combination therapy after they have reached at least 36 months of life. The study is a multicenter open label, randomized pilot study and will be conducted in different comprehensive care centers of the Pediatric Working group PAAD e.V. in Germany (www.kinder-aids.de).

After randomization one half of the children will interrupt their cART and re-start only if
CD4-cell count will be below 20% respectively <500/μl (3-5 years) or <350/μl (> 5 years) or if they show CDC class B or C symptoms. The control group will continue their cART without interruption. The study ends after 24 weeks and all children will be set to their usual cART again.

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Organizational Data

  •   DRKS00000473
  •   2011/01/17
  •   [---]*
  •   yes
  •   Approved
  •   E 8/10, Geschäftsnr. 58/10, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   B24 -  Unspecified human immunodeficiency virus [HIV] disease
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Interventions/Observational Groups

  •   Treatment arm - ART will be continued as usual
  •   Treatment interruption arm - usual ART will be interrupted for a maximum of 24 weeks or until there is an indication to restart ART.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Percentage of children without indication for ART after 24 weeks of ART-interruption.

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Secondary Outcome

Dynamics of CD4 cell count and increase of viral load, development of resistance mutations, occurence of CDC class B- and C symptoms/diseases, occurence of AIDS-defining illnesses, grade 3 or 4 lab-abnormalties according to DAIDS, changes of ART in control arm. All criteria will be checked at each visit (Screening, week 0, 2, 4, 6, 8, 12, 16, 20, 24, Follow-up) by clinical assessment and laboratory parameters.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2013/08/15
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   11   Years
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Additional Inclusion Criteria

Informed consent
Girls and Boys between 3 and 11 years
HIV infection under stable antiretroviral therapy based on a protease inhibitor
viral load <40cps
CD4 cells >30%
CDC classification N1 or A1
start of ART in first year of live, only because of age <12 months
participating in the ped. cohort of the competence network HIV/AIDS

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Exclusion Criteria

co-infection
NNRTI-based antiretroviral therapy
non-adherence
condition that interferes with study participation according to the study physician

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Addresses

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    • J.W. Goethe Universität Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dr.  Christoph  Königs 
    • Theodor-Stern-Kai 7
    • 60596  Frankfurt am Main
    • Germany
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    • J.W. Goethe Universität Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dr.  Christoph  Königs 
    • Theodor-Stern-Kai 7
    • 60596  Frankfurt am Main
    • Germany
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    • J.W. Goethe Universität Zentrum für Kinder- und Jugendmedizin
    • Studienteam 
    • Theodor-Stern-Kai 7
    • 60596  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.