Eligibility |
Inclusion Criteria:
- Chronic HIV-1 infected subjects followed in Department of Internal Medicine and
Clinical Immunology in Bicetre Hospital
- Healthy male or female aged between 20 and 69 (included) years
- Whatever the clinical status and the lymphocytes T CD4+
- Patients treatment-naive or under ARV treatment whatever the molecules
- 3 groups of patients, according to their HIV1 viral loads
- Virémic : viral load > 500 copies/mL, treatment-naive or treated (failing)
regardless of the cause of persistent viremic
- No Viremic : < 50 copies/ml under treatment at least from 12 months
- Spontaneous Controllers from the Codex Cohort (Controllers cohort from ANRS) or
not with the following inclusion criteria Chronic HIV-1 infected subjects since 5
years, asymptomatic With 5 last viral loads < 400 copies /mL Whatever the
lymphocytes T CD4 rates Naive of treatment except transient treatment for
prevention of mother-to-child transmission
- Subject considered to be free on the day of study of an acute condition or infection
that may interfere with the results of the study, based on the clinical examination
performed by the investigator
- Caucasian and Sub Saharan patients -18,5 = BMI = 32 kg/m²
- Subjects who, according to the investigator, can and will comply with the requirements
of the protocol and are available for the scheduled visit at the investigational site.
Ability to give their informed consent in writing
- Affiliated to the French social security or assimilated regimens
Exclusion Criteria:
Participation in another clinical study in the last 3 months
- Travel in (sub-) tropical countries within the last 3 months
- Pregnant women
- Infectious diseases:
- Acute opportunistic or not, current or past infection, within the last 3 months
as determined by the PI
- Ear temperature = 38.4 ° C on the day of inclusion
- Subject currently receiving or having received in the last 3 months antibiotics
or nasal, intestinal or respiratory antiseptics
- Severe/chronic/recurrent pathological conditions, among them:
- Past or present diagnosed cancer, lymphoma, leukemia to the exception of: Persons
with a history of cancer who are disease-free without treatment for 5 years or
more
- Women who are disease free for 3 years or more after treatment for breast cancer
and receiving long-term prophylactic tamoxifen
- Cutaneous or cervical basal cell carcinoma
- Personal history of organ transplant
- Congenital or acquired immune deficiency (any confirmed or suspected
immunosuppressive or immunodeficient condition, including history of HIV
infection)
- Personal history of auto-immune diseases requiring or having previously required
treatment (e.g. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sarcoidosis,
Ankylosing Spondylitis, Autoimmune Hemolytic Anemia, Autoimmune Thrombocytopenic
Purpura, Crohn's Disease, Psoriasis, Scleroderma, Wegener's Granulomatosis,Type I
Diabetes, Thyroiditis,….)
- Splenectomy
- Acute or chronic, clinically significant, as determined by the investigator,
pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined
by physical examination or laboratory
- Chronic renal impairment as defined by Renal Insufficiency: GFR<60 mL/min/1.73 m²
(National Kidney Foundation (2002)
- History of clinically significant, as determined by the investigator,
neurological disorder or seizures
- Any physical activity within 8 hours before the visit
- Any significant disorder of coagulation or treatment with warfarin derivatives
(AVK or ACO)or heparin or antiplatelet medications within 2 months preceding
inclusion
- Severe acute/chronic allergy
- Severe Asthma defined as asthma requiring a combination of two or more controller
therapies (e.g. medium or high dose inhaled glucocorticosteroid and long-acting
inhaled beta-2 agonist) or requiring oral glucocorticosteroids (GINA),
- Severe insect bite allergy with history of giant urticaria, Quincke edema or
anaphylactic shock
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within the 6 months prior to the inclusion. For
corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or
equivalent for > 2 weeks (inhaled and topical steroids allowed)
- Chronic administration of NSAIDs, including aspirin: prolonged intake (> 2 weeks)
within 6 months before study
- Receipt of blood products or immunoglobulins within 3 months prior the inclusion or
planning to receive blood products or immunoglobulins during the study
- Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
- Platelet count less than 120.000/mm3
- ALAT and/or ASAT > 3 times the upper limit of the norm (ULN)
- Receipt of any vaccination 3 months before the inclusion
- Alcohol abuse (more than 50 g of pure ethanol per day: for example, more than 4 x 150
mL glasses of wine, more than 4 x 250 mL glasses of beer, more than 4 x 40 mL glasses
of high alcohol content drinks
- Illicit drug use or substance abuse within 3 months prior to inclusion
|