9 April 2013 - 4:12pm by Webmaster | 19 April 2021 - 3:41pm by Gladys | ||
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Changes to Authorization date | |||
- | 2007-08-01 04:00:00 | + | 2007-08-01 00:00:00 |
Changes to Data sharing plan | |||
- | + | Not entered | |
Changes to Date of first enrollment | |||
- | 2008-02-21 05:00:00 | + | 2008-02-21 00:00:00 |
Changes to First name | |||
- | Jorge Perez Avila, MD. 2nd degree Specialist in Pharmacology | + | Jorge |
Changes to Last name | |||
- | Not entered | + | Perez Avila |
Changes to Health condition(s) code | |||
- | + | HIV | |
+ | HIV Infections | ||
+ | Lentivirus Infections | ||
+ | Retroviridae Infections | ||
+ | Immunologic Deficiency Syndromes | ||
+ | Sexually Transmitted Diseases, Viral | ||
+ | Sexually Transmitted Diseases | ||
+ | Immune System Diseases | ||
Changes to Medical Specialty | |||
- | + | MD. 2nd degree Specialist in Pharmacology | |
Changes to Affiliation | |||
- | Not entered | + | Pedro Kouri Institute of Tropical Medicine |
Changes to Postal address | |||
- | Not entered | + | Novia del Mediodía Freeway 6 1/2 between Nacional Freeway and Carretera Central |
Changes to Intervention code | |||
- | + | G(M3) Ganglioside | |
+ | N-Acetylneuraminic Acid | ||
+ | Adjuvants, Immunologic | ||
+ | Gangliosides | ||
+ | Proteolipids | ||
+ | Vaccines | ||
+ | Injections, Intramuscular | ||
+ | Placebos | ||
Changes to Intervention keyword | |||
- | + | NAcGM3/VSSP/Montanide ISA | |
Changes to City | |||
- | Not entered | + | Havana |
Changes to Country | |||
- | Not entered | + | Cuba |
Changes to Zip Code | |||
- | Not entered | + | 11400 |
Changes to 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. | + | 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.
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+ | 2. Patients who have never undergone anti-retroviral treatment.
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+ | 3. Patients of both sexes, aged 18 to 59 years.
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+ | 4. Reproductive-age females with confirmed negative pregnancy test, using appropriate double contraceptive method (intrauterine devices, hormonal contraceptives, surgical sterilization, barrier methods).
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+ | 5. Patients with Grade 0 to 2 Performance Status evaluation, according to WHO criteria.
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+ | 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.
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+ | 7. Patients who agree to participate in the trial by signing the Informed Consent. | ||
Changes to 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. | + | 1. Patients with a diagnosis of previous oncoproliferative diseases.
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+ | 2. Patients with other acute or chronic infectious diseases (Syphilis, Hepatitis B or C, Tuberculosis, Toxoplasmosis).
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+ | 3. Patients with acute allergic states or history of severe allergic reactions.
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+ | 4. Patients with autoimmune diseases or decompensated chronic diseases.
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+ | 5. Inability to understand informed consent.
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+ | 6. Patients who are receiving or have received in the three months prior to the study treatment with some other immunomodulator or vaccine preparation. | ||
Changes to Specialty | |||
- | + | First Degree Specialist in Oncology | |
Changes to Postal Address | |||
- | Calle 216 Esquina 15, Atabey, Playa | + | Street 216 corner 15, Atabey, Playa |
Changes to City | |||
- | Havana City | + | Havana |
Changes to Specialty | |||
- | + | First Degree Specialist in Oncology | |
Changes to Postal Address | |||
- | Calle 216 Esquina 15, Atabey, Playa | + | Street 216 corner 15, Atabey, Playa |
Changes to City | |||
- | Havana City | + | Havana |
Changes to Record Verification Date | |||
- | 2010-10-27 20:00 | + | 2021/04/19 |
Changes to Next update date | |||
- | + | 2022/04/19 |
Revision of 19 April 2021 - 3:41pm: