Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection

Korábbi kezelés

• Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
• Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry.
• Previous participation in a trial evaluating an immune modulating agent
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.

Más betegség

• Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody).
• Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
• Current history of cancer.
• Any conditions, including psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.

Laborértékek

• Abnormal laboratory tests results at screening: confirmed Hemoglobin \<11g/dl for women and \<12 g:dl for men/ confirmed platelet count \< 100000/l / confirmed neutrophil count \<1000/μl/ confirmed AST and/or ALT \> 3xULN

Egyéb

• Pregnancy or breastfeeding.

• Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acute seroconversion and incomplete Western Blot OR negative screening test within the past 6 months and incomplete Western Blot OR risk contact within the 3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot
• Able and willing to provide written informed consent
• Ability to attend the complete schedule of assessments and patient visits for patients participating in option A schedule (described below), or ability to attend a partial schedule of assessments and patient visits for patients participating in option B (described below).
• Ability and willingness to have blood and tissue samples collected and stored indefinitely and used for various research purposes.