HIV/AIDS
Conditions
Interventions
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
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 an
Vaccines
Injections, Intramuscular
Placebos
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion 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
Exclusion criteria: 1. Patients with a diagnosis of previous oncoproliferative diseases. 2. Patients with other acute or chronic infectious diseases (Syphilis, Hepatitis B or C, Tuberculosis, Toxoplasmosis). 3. Patients with acute allergic states or history of severe allergic reactions. 4. Patients with autoimmune diseases or decompensated chronic diseases. 5. Inability to understand informed consent. 6. Patients who are receiving or have received in the three months prior to the study treatment with some other immunomodulator or vaccine preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and immune potentiating effect. Measuring time: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Cuba
Contacts
Public ContactPedro Rodriguez Rodriguez
Center of Molecular Immunology(CIM)
Outcome results
None listed