Acquired immunodeficiency syndrome (AIDS)
Conditions
Interventions
Interventions in Phase I
Four Doses Level
Group I (experimental): NAcGM3/VSSP vaccine (dose 150 µg) will be administered by subcutaneous route. The first 5 doses will be administered each 14 days (± 7
Vaccines
Injections, Subcutaneous
Placebos
NAcGM3/VSSP
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have signed informed consent. 2. AIDS patients with antiretroviral treatment and evidence of multidrug resistance or with CD4 counts below 200 cells / uL for more than 2 consecutive assessments in the last 6 months with controlled viral load (not detectable or with values below the range 1 000 copies). 3. Patients aged between 18 and 50 years (including both). 4. Patients with overall according to WHO between 0 and 1. 5. Patients who have functioning of organs and bone marrow as defined by the following parameters (a) Hematopoietic: Hb>=100 g / L, Leukocytes>= 3 x 109 cells / L, granulocytes>= 1 x 109 cells / L, Platelets >= 150 x 109 cells / L; b) Liver (No more than five times the upper limit of normal (ULN) *), Bilirubin: 17 pmol / L (LSN *), ALAT: 40 U / L (LSN *) ASAT: 40 U / L (LSN *), Alkaline Phosphatase: 279 U / L *, LDH within normal levels: 214 U / L (LSN); c) Renal: Serum creatinine<= 132 pmol / L) 6. Life expectancy of 6 months or more.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received the investigational product . 2. Patients receiving other investigational product . 3. Patients with known hypersensitivity to any component of the formulation. 4. pregnant or lactating patients 5. Patients of childbearing age who are not using an appropriate method of contraception ( intrauterine devices, hormonal contraceptives , barrier methods or tubal ligation) . If male (vasectomy , condom use ) during treatment . 6. Patients with acute allergic conditions or history of severe allergic reactions. 7. Patients suffering from uncontrolled intercurrent illness including, but not limited to : active infections , symptomatic congestive heart failure, unstable angina , cardiac arrhythmia and psychiatric diseases involving the incompetence of the subject. 8. Patients with other malignant disease treated correctly in the previous 5 years , except in situ cancer. 9. Virus infection Hepatitis B or C. 10. Opportunistic at the time of inclusion in the study infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Optimal therapeutic dose (Level of dose in that they yield minor patients' number with new opportunistic diseases or deaths to the 12 months, once a minor toxicity was associated (adverse serious event, related to the formulation). Measuring time: 168, 336 days. Phase II Clinical response (Appearance of opportunistic bigger diseases or death in the period of treatment. The opportunistic diseases will be evaluated using the criteria of the Control Disease Center for AIDS patients of the United States). Measuring time: 168, 336 days. Adverse serious events related to with the formulation (The adverse events will be evaluated using the World Health Organization toxicity criteria). Measuring time: 168, 336 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunopotenciator Effect (It will evaluate based on the decrease or no increase in CD4 levels in the course of treatment). Measuring time: 168, 336 days. Virologic response (It will evaluate based on no increase in viral load in at least one decimal log or decrease it, in the course of treatment). Measuring time: 168, 336 days. Immunologic response (Values of CD3, CD4, CD8, NK, CD4CD25FoxP3. The result will be collected by those units in the institution). Measuring time: 168, 336 days. Quality of life (It will evaluate through the Spanish version of the MOS-HIV (for its acronym in English Medical Outcomes Study -Human Immunodeficiency Virus), validated in the Cuban population by IPK. It is a questionnaire of Quality of life for aids Cuban patients). Measuring time: 0, 168, 336 days. Safety. Toxicity (Occurrence of any EA, description, duration, intensity, severity, outcome, attitude towards treatment and causation). This outcome will measure every 28 days. - Occurrence of any AE (Yes, No) - Description AE (name of the event) - Duration of AE (Difference between the start and end dates of the adverse event) - AE Intensity (It is classified according to the nomenclature and intensity criteria to assess the severity of adverse events in AIDS patients adult and pediatric version 1.0, December 2004; with clarification of August 2009. It includes the following categories: mild, moderate, severe, EA potentially life-threatening or EA that produces death. - Causality relationship (1. Final, 2. Very Likely, 3. Probable, 4.Possible. 5. Not related, 6.Unknown) - Seriousness / Gravity (Serious, Not serious. Are severe/serious adverse events those that 1. Produce death, 2. Threaten life, 3. Require / prolonged hospitalization, 4. Produce disability / persistent or significant disability or 5. Produce birth defect or congenital anomaly) Results of laboratory tests. Measuring time: every 28 days. Hematopoietic Laboratory (Hb (g/L), Leukocyte (109 cells/L), Granulocyte (109 cells/L | — |
Countries
Cuba
Contacts
Public ContactVianka Calas Hechevarria
Tropical Medicine Institute Pedro Kouri (IPK)
Outcome results
None listed