Safety and preliminary therapeutic effect of teravac HIV vaccine candidate in chronic HIV-1.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点目标入组 28 人开始时间: 2011年8月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•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.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.