Teravac HIV in chronic HIV-1.
- Conditions
- Infection HIV.
- Registration Number
- RPCEC00000121
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 28
1) Male adult. 2) Aged between 18 and 50 years old. 3) VIH 1 Positive, subtype B. 4) Nadir T cells CD4+ >350 cells / mL. 5) Treatment ART, viral load <50 copias de ARN/ mL. 6) Voluntariness of the patient by signing the informed consent. 7) General condition index according to WHO grade 0. 8) Normal basic hematological: hemoglobin, hematocrit, total leukocyte count, differential white blood cell count (neutrophils, eosinophils, lymphocytes, monocytes), erythrocyte sedimentation rate, counts platelets 9) Normal clinical chemistry serum titers (pyruvic transaminase, oxaloacetic transaminase, alkaline 10) phosphatase, uric acid, urea, creatinine, prothrombin time, urine protein, total bilirubin, direct bilirubin, glucose, cholesterol, triglycerides). 11) Patients who do not have received any blood transfusion 30 day before start clinical trial. 12) Concomitant treatment of ART until week 16 of clinical trial.
1) Positive for serological markers of infection with hepatitis C and B. 2) Uncompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, malignant neoplasia, epilepsy, severe mental depression, hepatic cirrhosis, or primary liver hepatocacinoma). 3) Underlying immunosuppressive disease or immunosuppressive / immunostimulantory drugs intake (including steroids) in the six month prior to study entry. 4) Autoimmune disease. 5) Inflammatory gut disease, psoriasis, optic neuritis or another disease potentially life threatening. 6) Acute diseases of respiratory airways, hepatic failure, renal failure, uncompensated cardiopathy. 7) History of severe allergy that need continued treatment with steroids (Grade III or IV Asthma, urtycaria, dermatitis, bronchitis, etc). 8) Cytotoxic chemotherapy by malignance. 9) Hemophilia diagnosis of or other bleeding disorder. 10) Immunomodulators, biological response modifiers, chemotherapy use or other drugs under investigation within 45 days prior to randomization and can not be discontinued for the duration of the study. 11) Opportunistic diseases related VIH. 12) concurrent malignancies. 13) Obvious mental incapacity to give written consent or to allow follow up of the patient. 14) Disorder in the nasal cavity that prevents the implementation of HIV vaccine candidate therapeutic teravac. 15) Alcohol and drug patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method