NAcGM3/VSSP-aids-patients drug resistant to antiretroviral treatment-Phase I-II

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

NacGM3/VSSP AIDS Phase I/II

Scientific title:

Evaluation of safety and effect of four doses level of NAcGM3/VSSP formulation as immunopotentiator by subcutaneous route in the treatment of aids patients drug resistant to antiretroviral treatment.

Acronym of Scientific Title:

Not applicable

Secondary indentifying numbers:

IICRD-EC-155

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM)Tropical Medicine Institute Pedro Kouri (PK)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

27/10/2014

Reference number:

05-009-14BC

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Vianka

Last name:

Calas Hechavarria

Medical Specialty :

Second Degree in Internal Medicine

Affiliation:

Tropical Medicine Institute Pedro Kouri (IPK)

Postal address:

Autopista Novia del Mediodía km 6½ entre Autopista Nacional y Carretera Central

City:

Havana

Country:

Cuba

Zip Code:

17100

Telephone:

+53-72553451

+53-72553236

Email address:

vianka@ipk.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Tropical Medicine Institute “Pedro Kouri”, March 18th, 2014

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

28/01/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acquired immunodeficiency syndrome (AIDS)

Health condition(s) code:

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Immune System Diseases

Intervention(s):

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 days of tolerance), the next 10 doses will be administered each 28 days (± 15 days of tolerance), to complete a year of treatment. Group II (experimental): NAcGM3/VSSP vaccine (dose 300 µg) will be administered by subcutaneous route. The first 5 doses will be administered each 14 days (± 7 days of tolerance), the next 10 doses will be administered each 28 days (± 15 days of tolerance), to complete a year of treatment. Group III (experimental): NAcGM3/VSSP vaccine (doses 600 µg) will be administered by subcutaneous route. The first 5 doses will be administered each 14 days (± 7 days of tolerance), the next 10 doses will be administered each 28 days (± 15 days of tolerance), to complete a year of treatment. Group IV (experimental): NAcGM3/VSSP vaccine (doses 900 µg) will be administered by subcutaneous route. The first 5 doses will be administered each 14 days (± 7 days of tolerance), the next 10 doses will be administered each 28 days (± 15 days of tolerance), to complete a year of treatment. Patients who presented favorable response to the treatment, after 15 administration, will can continuous with the same administration of formulation every 28 days (± 15 days of tolerance, always remain with the performance status during the follow of protocol another year and after that under clinical consideration. Interventions in Phase II Group I ( study) : Depending on the selected dose Phase I is administered subcutaneously , the first 5 doses at intervals of 14 days ( ± 7 days tolerance), the following 10 doses at intervals of 28 days ( ± 15 days tolerance ) to complete one year of treatment . Group II (control) : Placebo to be received by the same route following the same frequency and duration of the study group After all patients receive the 15 administrations of the formulation or placebo, blinding opens for each patient individually. Patients in the study group to submit favorable response to treatment may also continue administrations at intervals of 28 days (tolerance +/- 15 days) during the follow-up protocol for another year and then to medical judgment.

Intervention code:

N-Acetylneuraminic Acid

G(M3) Ganglioside

Adjuvants, Immunologic

Gangliosides

Proteolipids

Vaccines

Injections, Subcutaneous

Placebos

Intervention keyword:

NAcGM3/VSSP

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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), Platelets (109 cells/L). Measuring time: every 28 days. Liver Laboratotry (Bilirubin (µmol/L), ALAT (U/L), ASAT (U/L), Alkaline Phosphatase (U/L), LDH (U/L)). Measuring time: every 28 days. Renal Laboratory (Serum Creatinine (µmol/L)). Measuring time: every 28 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

50 years

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:

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1-2

Target sample size:

25

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Vianka

Last Name:

Calas Hechevarria

Specialty:

Second Degree Specialist in Internal Medicine

Affiliation:

Tropical Medicine Institute Pedro Kouri (IPK)

Postal Address:

Autopista Novia del Mediodia km 6½ entre Autopista Nacional y Carretera Central

City:

Havana

Country:

Cuba

Zip Code:

17100

Telephone:

+537 255 3451

Email :

vianka@ipk.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Adriana

Last Name:

Carr Perez

Specialty:

Biochemist. PhD in Health Sciences Biochemist

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 y 15 , Atabey; Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53 7 214 3168

Email :

adriana@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000213

Date of Registration in Primary Registry:

22/04/2016

Record Verification Date:

2023/08/02

Next update date:

2024/08/02

Link to the spanish version:

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NAcGM3/VSSP-aids-patients drug resistant to antiretroviral treatment-Phase I-II

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