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Characterization of HIV-1 Antibody Resistance in Patients

Recruiting
Conditions
B24
Unspecified human immunodeficiency virus [HIV] disease
Registration Number
DRKS00027018
Lead Sponsor
niversitätsklinikum Köln
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
210
Inclusion Criteria

18 years or older
- Karnofsky-Index =80%
- HIV Infection

Exclusion Criteria

Only for blood draws >100ml:
- Hemoglobin <13.5 g/dL (men) or <12.5 g/dL (women)
- Symptomatic heart disease (e.g., heart failure NYHA =II, coronary artery disease,
previous myocardial infarction).
- Has had a myocardial infarction.
- Stage GOLD III-IV COPD.
- Body weight less than 45kg (To perform a blood draw of =250 mL
there must be a body weight of at least 50 kg)
- <8 weeks (men) or <12 weeks (women) since last blood volume draw of =500 mL
- Known acquired or hereditary coagulation disorder, including therapeutic Anticoagulation
- Within one week of a minor surgery (e.g., biopsy, tooth extraction, etc.), or one month after major surgery (e.g., opening of the chest cavity or abdomen) or other surgery with increased risk of postoperative bleeding (e.g., removal of the palatine tonsils [tonsillectomy]).
- Current participation in an interventional study. Current participation is defined as when the patient is in the treatment or follow-up phase of a clinical trial, or when another interventional procedure has been performed or is planned for another type of study in temporal relation to the leukapheresis or blood collection. In the latter case, it is crucial that an overlap of study-related harms or a disproportionate burden for the patient is excluded from a medical point of view.

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Recruiting 210 patients
Secondary Outcome Measures
NameTimeMethod
Does not apply.
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