Teravac HIV in chronic HIV-1.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

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

Secondary indentifying numbers:

IG/VHIN/VIH/0801

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB).

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

17/06/2011

Reference number:

05-009-10-B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Lorenzo Jorge Pérez Ávila, MD. 2nd grade Specialist in Pharmacology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Havana, “Pedro Kouri” Tropical Medicine Institute, June 11, 2010.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

03/10/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

- 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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

18 years

Maximum age:

50 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MsC. María

Middle Name:

Mercedes

Last Name:

Vázquez Marcos

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

maria.vazquez@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

DrC. Enrique

Last Name:

Iglesias Pérez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

enrique.iglesias@cigb.edu.cu [3]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000121

Date of Registration in Primary Registry:

2011-08-10

Record Verification Date:

2011-08-04 20:00

Link to the spanish version:

Click here [4]