Trial document




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  DRKS00000722

Trial Description

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Title

Noninterventional Study of Safety, Efficacy, Adherence, and Health Related Quality of Life in Patients Receiving a Once Daily Single Tablet Regimen for HIV 1 Infection in Germany
STR-NIS – (STRike)

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Trial Acronym

STRike

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Long term documentation of single tablet regimen (all HIV therapy components in a single pill) in a routine setting within a non interventional trial.
Treatment will be according to local medical practice. Data on efficacy (viral load, CD4 cell count), quality of life, adherence and side effects will be collected and described statistically.

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Brief Summary in Scientific Language

In this noninterventional observational German STR cohort we are planing to document long term treatment (2 years therapy) with single tablet regimens and collect data on patient related outcome, about quality of life, adherence and preference of treatment. Data on efficacy (HIV RNA, CD4 cell count) and side effects will also be gathered. Data will be analyses using descriptive statistics.

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Organizational Data

  •   DRKS00000722
  •   2011/02/25
  •   [---]*
  •   no
  •   Approved
  •   10-4578, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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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

  •   Observational group 1: Atripla use started 12-24 months prior to enrollment
  •   Observational group 2: Atripla use starting with enrollment, SF 36 questionnaire at Enrollment, and approx. 1,2,3,6,9,12,18 and 24 months after enrollment
  •   Observational group 3: Eviplera use starting at enrollment (after marketing approval), SF 36 questionnaire at Enrollment, and approx. 1,2,3,6,9,12,18 and 24 months after enrollment
  •   Observational group 4: Stribild use starting at enrollment (after marketing approval), SF 36 questionnaire at Enrollment, and approx. 1,2,3,6,9,12,18 and 24 months after enrollment
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm, Other
  •   Treatment
  •   Other
  •   IV
  •   [---]*
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Primary Outcome

Viral load (HIV RNA) at month 24

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Secondary Outcome

SF 36 Quality of life (change from Baseline, each visit)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/03/24
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Arm 1 and 2: Adults with HIV-1-infection, who are with their current antiretroviral combination therapy virologically suppressed (HIV-1-RNA < 50 copies/ml) for at least three months.
Arm 3: Antiretroviral naive adults with HIV-1-infection and viral load of <= 100.000 copies HIV-1-RNA/ml
arm 4 - Adults with HIV-1 infection, who are antroretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild

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Exclusion Criteria

Patients not fulfilling the inclusion criteria.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Gilead Sciences GmbH
    • Ms.  Dr.  Marion  Heinzkill 
    • Fraunhoferstr. 17
    • 82152  Martinsried
    • Germany
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    • Gilead Sciences GmbH
    • Ms.  Dr.  Marion  Heinzkill 
    • Fraunhoferstr. 17
    • 82152  Martinsried
    • Germany
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    • Gilead Sciences GmbH
    • Ms.  Dr.  Marion  Heinzkill 
    • Fraunhoferstr. 17
    • 82152  Martinsried
    • Germany
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Sources of Monetary or Material Support

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    • Gilead Sciences GmbH
    • Ms.  Dr.  Marion  Heinzkill 
    • Fraunhoferstr. 17
    • 82152  Martinsried
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/06/24
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Trial Publications, Results and other Documents

  •   N/A
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* This entry means the parameter is not applicable or has not been set.