AcGM3/VSSP/Montanide ISA 51 formulation in HIV, phase II.

Phase 2

Recruiting

• Conditions: HIV/AIDS; HIV Infections; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immune System Diseases

• Registration Number: RPCEC00000015
• Lead Sponsor: Center of Molecular Immunology(CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 118

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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and immune potentiating effect. Measuring time: 12 months

Secondary Outcome Measures

Name	Time	Method
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