NAcGM3/VSSP/Montanide ISA 51 formulation in HIV, phase II.

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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:

Evaluation of the immune potentiating effect of the NAcGM3/VSSP/Montanide ISA 51 formulation in HIV patients, phase II.

Secondary indentifying numbers:

IIC RD-EC087

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Government funds

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 :

01/08/2007

Reference number:

1463/05.003.07B

Principal investigator

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

First name:

Jorge Perez Avila, MD. 2nd degree Specialist in Pharmacology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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:

Institute of Tropical Medicine Pedro Kouri (IPK), December 4th,2006.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

21/02/2008

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:

HIV/AIDS

Intervention(s):

The study includes 2 treatment groups. Group I. Vaccine preparation This group will be administered 0.7 ml of (NAcGM3/VSSP)+Montanide ISA 51 vaccine. Group II. Placebo This group will be administered 0.7 ml of (Tris -HCl )+Montanide ISA 51 placebo. Both groups will receive a total of 15 vaccines by intramuscular route. The first 5 vaccines at 14 day intervals and the rest at 28 day intervals. The vaccine will be given in the deltoid region and gluteal region, if necessary; care must be taken to inject the muscle rather than the adipose panniculus around it. HIV patients included in the study will not be on anti-retroviral therapy during the study. If patients require anti-retroviral drugs, the treatment will be considered interrupted.

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):

Safety and immune potentiating effect. Measuring time: 12 months

Key secondary outcomes:

Performance of CD4+ leukocyte subpopulations in absolute cell counting and relative proportional values of total leukocytes, viral load, clinical evolution including absolute CD4 values, viral load and progression time, evolution of clinical laboratory parameters, and specific antibody response against the NAcetyl GM3 ganglioside. Measuring time: 12 months

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

59 years

Inclusion criteria:

1. HIV patients with CD4+ values between 350 and 500 cells, relative CD4 values between 14 and 28% of total leukocytes, and viral load values between 30,000 and 100,000 copies. 2. Patients who have never undergone anti-retroviral treatment. 3. Patients of both sexes, aged 18 to 59 years. 4. Reproductive-age females with confirmed negative pregnancy test, using appropriate double contraceptive method (intrauterine devices, hormonal contraceptives, surgical sterilization, barrier methods). 5. Patients with Grade 0 to 2 Performance Status evaluation, according to WHO criteria. 6. Clinical laboratory parameters: a.-) hematopoietic parameters: Hb>100g/l- leukocytes> 4 x 109 cells/l, - granulocytes > 2 x 109 cells/l- platelets > 150 x 109 cells/l; b.-) Liver (not exceeding normal upper limit by three times)- bilirubin: 17 umol/l (LSN)- ALAT: 40 U/l (LSN)- ASAT: 40 U/L (LSN)- alkaline phosphatase: 279 U/l; c.-) Kidney: - serum creatinine < 132 umol/l; d.-) LDH (not exceeding twice the normal upper limit) – 240 - 480 U/l. 7. Patients who agree to participate in the trial by signing the Informed Consent.

Exclusion criteria:

1. Pacientes VIH con valores de CD4+ entre 350 y 500 celulas, valores relativos de CD4 entre 14y 28 % del total de Leucocitos y valores de carga viral entre 30 000 y menor de 100 000 copias. 2. Pacientes vírgenes de tratamiento antirretroviral. 3. Pacientes de ambos sexos con edades comprendidas entre 18 y 59 años. 4. Las pacientes en edad fértil con confirmación de prueba de embarazo negativa y con empleo de doble método contraceptivo adecuado (dispositivos intrauterinos, anticonceptivoshormonales, esterilización quirúrgica de trompas, métodos de barreras) 5. Pacientes con evaluación de la capacidad funcional (Performance Status) de Grado 0 a 2, según criterios de la OMS. 6. Parámetros de laboratorio clínico. a.-) Hematopoyéticos: - Hb>100g/L- Leucocitos> 4 x 109 células/ L- Granulocitos > 2 x 109 células/L- Plaquetas > 150 x 109 células/ L b.-) Hepáticos (No mayor de tres veces el límite superior normal)- Bilirrubina: 17 umol/L (LSN)- ALAT: 40 U/L (LSN)- ASAT: 40 U/L (LSN)- Fosfatasa Alcalina: 279 U/L c.-) Renal: - Creatinina sérica < 132 umol/L. d.-) LDH (No mayor del doble al límite superior normal)- 240-480 U/L 7. Pacientes que acepten su participación en el ensayo, firmando el Consentimiento Informado.

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:

2

Target sample size:

118

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:

Pedro

Middle Name:

Camilo

Last Name:

Rodriguez Rodriguez

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

camilo@cim.sld.cu

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:

Pedro

Middle Name:

Camilo

Last Name:

Rodriguez Rodriguez

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

camilo@cim.sld.cu

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:

RPCEC00000015

Date of Registration in Primary Registry:

2010-12-29

Record Verification Date:

2010-10-27 20:00

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

NAcGM3/VSSP/Montanide ISA 51 formulation in HIV, phase II.

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