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

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000015
• Date of registration: 29/12/2010
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: NAcGM3/VSSP/Montanide ISA 51 formulation in HIV, phase II.
• Scientific title: Evaluation of the immune potentiating effect of the NAcGM3/VSSP/Montanide ISA 51 formulation in HIV patients, phase II.
• Date of first enrolment: 21/02/2008
• Target sample size: 118
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000015-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: Pedro Rodriguez Rodriguez
• Affiliation: Center of Molecular Immunology(CIM)

• Name: Pedro Rodriguez Rodriguez
• Affiliation: Center of Molecular Immunology(CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 59 years
Gender: Both

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.

Primary Outcome(s)

Safety and immune potentiating effect. Measuring time: 12 months

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC087

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable