Infection HIV.
Conditions
Interventions
Group I (experimental): HIV Teravac 50 mg Grupo II (Control): placebo The product is administered by doses subcutaneously in the deltoid region of arm and nasal route using a spray device (Valois) tro
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Not aplicable.
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: 72 hours after having given every dose of therapy and at weeks 15, 18, 22, 27, 33, 36 and 40. - Certain hematologic (hemoglobin, hematocrit, white blood cell count with differential, ESR, platelet count). Measuring time: weeks 0, 3, 7, 15, 20, 27 and 40. - Biochemical (pyruvic transaminase blood levels, oxaloacetic transaminase, alkaline phosphatase, uric acid, urea, creatinine, prothrombin time, protein in urine, bilirubin, glucose, cholesterol, triglycerides). Measuring time: weeks 0, 3, 7, 15, 20, 27 and 40. - Vital signs (temperature, blood pressure). Measuring time: weeks 0, 1, 2, 4, 8, 12, 15, 18, ??22, 27, 33, 36 and 40. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Measurement of viral load (quantitative variable). Measuring time: weeks 0, 3, 7, 11, 15, 18, 20, 22, 24, 27, 30, 33, 36 and 40. - Counts of T lymphocytes (CD3 + cell count and CD4 +). Measuring time: weeks 0, 3, 7, 11, 15, 18, 20, 22, 24, 27, 30, 33, 36 and 40. - Counts of T lymphocytes (CD3 +, CD8 + (CTL), CD3-, CD16 +, CD56 + (NK)). Measuring time: weeks 0, 15 and 40. - Delayed hypersensitivity reaction - DTH (anergic, reactive). Measuring time: weeks 0 and 15. - Immunological tests in vitro and ex vivo (determination of antibodies: IgG, IgG subclasses in serum and nasal washes antibodies: CR3, Nef, p24, core and surface discharge of chemokines (MIP-1alpha and MIP-1beta) in supernatants culture and ELISPOT IFN gamma / IL-2 (stimuli: a mixture of peptides p24, Nef, RT, gp160 and p24 proteins, Pol, gp160)). Measuring time: weeks 0, 7, 11, 15, 24 and 40. - Quality of Life Survey (MOS-SF-30). Measuring time: weeks 0, 4, 8, 12, 18, ??22, 27, 30, 33, 36 and 40. | — |
Countries
Cuba
Contacts
Public ContactMsC. María Vázquez Marcos
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed