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

Recruiting

Conditions: B24
Unspecified human immunodeficiency virus [HIV] disease

Registration Number: DRKS00000288

Lead Sponsor: HIVCENTERMedizinische Klinik IIKlinikum der J. W. Goethe-Universität

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.<br>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.