Trial document




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  DRKS00000288

Trial Description

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Title

Investigation of platelet function and formation of platelet-leukocyte aggregates during initial antiretroviral therapy of HIV-infected adults over 48 weeks

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Trial Acronym

HIV-PLAII

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

platelet function and formation of platelet-leukocyte-aggregates in 50 HIV infected patients with new indication for antiretroviral therapy will be monitored before and over 48 weeks during initial antiretroviral therapy. Blood will be taken in addition to routinely taken samples for further examination. Two regimens of therapy are available (proteinase-inhibitor containing and non-nucleotid-reverse-transcriptase-inhibitor containing therapy, respectively). 25 patients each are to be included into the study.

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Brief Summary in Scientific Language

Increased platelet-activation can be observed in HIV-infected patients. It is not shown by now if this is an effect of the disease itself (eg. caused by virus load) or a side-effect of therapy with proteinaseinhibitors. Platelets cause progression of atherosclerosis and can lead to thrombotic events. Besides direct effects on growth reactions due to release of platelet factors there is an interaction between platelets and leukocytes that induces synthesis and release of leukocyte mediators, which support inflammatory processes in the vasculature. Platelet-activation and formation of platelet-leukocyte-aggregates are to be examined in two groups of HIV-infected patients who have not yet received any HIV-specific therapy, and will now receive an initial antiretroviral therapy (PI-containing vs. NNRTI-containing therapy). Results of this scientific approach could initiate a clinical observation of a therapy that suppresses the formation of platelet-leukocyte-aggregates specifically (i.e. with Clopidogrel), if an increase of PLA-formation will be shown in this present study.
Furthermore tissue factor pathway inhibitor (TFPI)-levels are to be observed.

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Organizational Data

  •   DRKS00000288
  •   2010/02/17
  •   [---]*
  •   yes
  •   Approved
  •   290/09, 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

  •   Blood withdrawals for determination of platelet function and formation of platelet-leukocyte aggregates on an observational cohort of HIV infected patients, now under initial antiretroviral treatment with protease inhibitors (PI). Samples are withdrawn before and 4, 12, 24 and 48 weeks after therapy beginning on dates when the patients will come routinely for their control visits. Samples will be collected together with the clinically indicated blood collections. Antiretroviral treatment by itself displays no intervention, solely the collection of an additional blood volume of 10ml whilst the clinically indicated blood collection for platelet/coagulation parameter examination does.
  •   Blood withdrawals for determination of platelet function and formation of platelet-leukocyte aggregates on an observational cohort of HIV infected patients, now under initial antiretroviral treatment with nonnucleoside reverse transcriptase inhibitors (NNRTI). Samples are withdrawn before and 4, 12, 24 and 48 weeks after therapy beginning on dates when the patients will come routinely for their control visits. Samples will be collected together with the clinically indicated blood collections. Antiretroviral treatment by itself displays no intervention, solely the collection of an additional blood volume of 10ml whilst the clinically indicated blood collection for platelet/coagulation parameter examination does.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Determination of parameters of inflammatory reaction (platelet-leukocyte-aggregates, CD40L) with the COULTER EPICS XL-MCL flow cytometer. The experiments will be done by staining with specific fluorescence-labelled antibodies. Baseline values as well as values after stimulation will be determinated. Determinations will be done from whole blood from samples drawn during the visits.

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Secondary Outcome

Determination of parameters of platelet- and leukocyte aktivation (CD62, PAC-1, CD11b) with the COULTER EPICS XL-MCL flowcytometer. The experiments will be done by staining with specific fluorescence-labelled antibodies. Baseline values as well as values after stimulation will be determinated. Determinations will be done from whole blood from samples drawn during the visits. Thrombin generation (ETP), measured on a Fluoroskan Ascent Type 374 microplate fluorometer. This will be done from platelet rich plasma (PRP) at the timepoints of the visits. Baseline values as well as values after stimulation will be determinated. TFPI plasma levels - measured with ELISA-technique.
Determination will be done from platelet poor plasma (PPP) at the timepoints of the planned visits. The platelet poor plasma will be stored at -20°C until analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/03/02
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- patients with assured HIV-1-infection
- therapy-naive patients; patients that took ART (antiretroviral therapy) medication for not longer than two weeks in context with a clinical study more than 3 months before inclusion into this observational study, should be regarded as therapy-naive, too.
- treated ambulantly or in hospital
- written informed consent

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Exclusion Criteria

- neurological diseases, influencing the patients? cognition
- manifest psychoses and/or severe psychiatric diseases that seem to interfere with the patients? comprehension for the sense, risk and needs of this study
- apparent limitations of compliance due to addiction to, drugs or pharmaceuticals
- haemoglobin < 10g/dl in men or < 8g/dl in women, respectively
- thrombocytopenia with < 50.000 platelets/µl blood
- known and untreated blood coagulation disorders
- diabetes
- untreated hypertension with a systolic/diastolic blood pressure of > 140/90
- cholesterol plasma levels of > 250mg/dL
- body mass index (BMI) > 35
- strong smokers with a consume of more than 10 cigarettes daily
- intake of non steroidal anti inflammatory drugs (NSAIDs) like diclofenac, acetylsalicylic acid (ASA) etc. less than 7 days before the screening date
- intake of oral anticoagulants, inhibitors of platelet aggregation like clopidogrel, acetylsalicylic acid (ASA) and dipyridamole

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Addresses

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    • HIVCENTER Medizinische Klinik II Klinikum der J. W. Goethe-Universität
    • Mr.  PD Dr. med. Nils  von Hentig 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • HIVCENTER Medizinische Klinik II Klinikum der J. W. Goethe-Universität
    • Mr.  PD Dr. med. Nils  von Hentig 
    • Theodor-Stern-Kai 7
    • 60590 Frankfurt am Main  Frankfurt am Main
    • Germany
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    • HIVCENTER HIV-Schwerpunkt im Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Zentrum der Inneren Medizin Medizinische Klinik II Haus 68 1. OG Telefax 069 6301-83425
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
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Sources of Monetary or Material Support

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    • Dekanat des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt am Main Forschungsreferat (u.a. Vergabe von Stiftungsmitteln)
    • Ms.  Dr.  Barbara  Pardon (Forschungsreferentin) 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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.