Teravac HIV in chronic HIV-1.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000121
• Date of registration: 10/08/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: Teravac HIV in chronic HIV-1.
• Scientific title: Safety and preliminary therapeutic effect of teravac HIV vaccine candidate in chronic HIV-1.
• Date of first enrolment: 03/10/2011
• Target sample size: 28
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000121-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: DrC. Enrique Iglesias Pérez
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: MsC. María Vázquez Marcos
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: 50 years
Gender: Male

Health Condition(s) or Problem(s) studied

Infection HIV.

Intervention(s)

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) trough the weeks 0, 1, 2, 4, 8, and 12 (of the 40 weeks that includes the clinical trial). Antiretroviral therapy interruption after 16 weeks clinical trial and reintroduction at the discretion medico group.

Primary Outcome(s)

- 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 Outcome(s)

- 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.

Secondary ID(s)

IG/VHIN/VIH/0801

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB).

Secondary Sponsor(s)

Not aplicable.