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

Center of Molecular Immunology(CIM)0 个研究点目标入组 118 人开始时间: 2010年12月29日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

Center of Molecular Immunology(CIM)