Evaluation of Biomodulin T® in patients with HIV/AIDS. Phase II/III.

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:

ECBMTVIH

Scientific title:

Evaluation of the efficacy and safety of Biomodulin T® as a complementary therapy to antiretroviral treatment compared to antiretroviral therapy in patients with HIV/AIDS. Phase II/III.

Secondary indentifying numbers:

GEC2018BMT021

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BIOCEN)

Source(s) of monetary or material support:

National Center of Bioproducts (BIOCEN) Ministry of Public Health (MINSAP)

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)

Reference number:

In process

Principal investigator

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

First name:

Rene

Last name:

Rodriguez-Feo Cou

Medical Specialty :

Specialist in Integral General Medicine. Master in infectious diseases.

Affiliation:

Provincial Health Office of Mayabeque.

Postal address:

130 Street without number, between 47th and 65th , Chavez neighborhood, Jamaica, San Jose de las Lajas.

City:

Mayabeque

Country:

Cuba

Zip Code:

32700

Telephone:

+53-47848426

Email address:

renerf@infomed.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:

Mayabeque, Batabano, "Pascuala Restituta" Polyclinic, Francisco Yings Marrero, MD, Specialist in Integral General Medicine, Doctor Attention to People live with HIV (PVV).

Mayabeque, Bejucal, "Rosa Elena Simeon" Polyclinic, Yanelis Aldana, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, Guines, "Luis Li Trigens" Polyclinic, Adianes Coto Barroso, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, Quivican, "Pablo Noriega" Polyclinic, Vivian Álvarez Millares, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, Madruga, "Maria Emilia Alfonso" Polyclinic, Marlen Lizaso Marrero, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, Melena del Sur, Policlinico "Raul Curras", Eduardo Regalado Garcia, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, Nueva Paz, "Felipe Poey" Polyclinic, Sandra Malvares Castellanos, MD, Specialist in Integral General Medicine, Head of the PVV Program.

Mayabeque, Jaruco, Policlínico "Noelio Capote", Marianela Vidal Valdez, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, San Jose de las Lajas, "Rafael Echezarreta" Polyclinic, Yailin Ramírez Delgado, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, Santa Cruz, "Alberto Fernandez" Polyclinic, Yanisbel Barroso Cardet, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Mayabeque, San Nicolas, "Emilia de Cordova" Polyclinic, Ernesto Milian Suarez, MD, Specialist in Integral General Medicine, Doctor Attention to PVV.

Research ethics committees:

Centralized Ethics Committee. University of Medical Sciences of Mayabeque, June 18, 2018

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

31/10/2018

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:

Human Immunodeficiency Virus

Health condition(s) code:

HIV

HIV Infections

Lentiviruses Infections

Retroviridae Infections

RNA Viruses Infections

Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Environmental Illness

Virus Diseases

Intervention(s):

Stage I Group I BMT+TARVAE (Experimental): High-Efficacy Antiretroviral Therapy (HART) + Biomodulin T (BMT). Patients will receive BMT in the scheme 1 with 3 mg (1 bbo) by intramuscular route, 2 times per week for 4 weeks. Then patients will receive 3 mg a week for 8 weeks, then it will rest for 8 weeks too and, the cycle is repeated. Group II BMT+TARVAE (Experimental): High-Efficacy Antiretroviral Therapy (HART) + Biomodulin T (BMT). Patients will receive BMT in the scheme 2 with 3 mg (1 bbo) by intramuscular route, weekly for 12 weeks. Then patient will rest for 8 weeks and, the cycle is repeated. Group III TARVAE (Control): Only high-efficacy antiretroviral therapy treatment (HART). Stage II Group I (Experimental). The group of BMT selected from the stage I Group II (Control): Only High-Efficacy antiretroviral therapy treatment (HART).

Intervention code:

Anti-Retroviral Agents

Injections, Intramuscular Biomodulin T

Intervention keyword:

Biomodulin T

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):

1. CD4 + count (Result of the CD4 + T cell count, expressed in cells / μL and %). Measurement time: At baseline, week 20 and 40 (final evaluation). 2. Clinical response (It will be recorded by the yes / no dichotomous response, taking into account the appearance or not of new opportunistic diseases during the 40 weeks after the start of treatment). Measurement time: Week 40 (final evaluation).

Key secondary outcomes:

1. Virological response (It will be evaluated according to the non-increase of the viral load (given in cp/ml) in at least one decimal logarithm or decrease thereof, in the course of the treatment.) Measurement time: At baseline, week 20 and 40 (final evaluation). 2. Quality of Life (It will be evaluated through the Spanish version of the MOS-HIV questionnaire (for its acronym in English Medical Outcomes Study-Human Immunodeficiency Virus), validated in the Cuban population in the IPK. Measurement time: At baseline, week 20 and 40 (final evaluation). 3. Adverse Events-AE (Occurrence of an AE (Yes, No), Description of the AE(Name of the adverse event), According to the available previous information (Unexpected, Expected), Duration of the AE (Difference of time between the start and the termination of the AE), intensity of the AE (mild, moderate, severe), severity of the AE (serious and not serious), attitude towards the treatment under study (no changes, dose modification, temporary interruption, definitive interruption of treatment), result of AE (Recovered, Improved, Persists, Sequelae), Causality relation (1. Very likely, 2. Probable, 3. Possible, 4. Not likely, 5. Not related, 6. Not evaluable)). Measurement time: weekly until week 40.

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:

None

Inclusion criteria:

1. HIV/ AIDS patients with at least three months after the start of HART. 2. Patients who have signed the informed consent. 3. Patientswith ages ≥ 18years. 4. Patients with general status evaluation between 0 and 1, according to WHO criteria. 5. Patients who have functioning of organs and bone marrow defined by the following parameters: a) Hematopoietic: Hemoglobin: ≥100 g/L Leukocytes: ≥ 3 x 109 cells/L Platelets: ≥ 150 x 109 cells /L b) Hepatic (Not greater tan three times the upper normal limit (UNL)) SGPT: 40 U/L (UNL) SGOT: 40 U/L (UNL) ALP: 279 U/L (UNL) Renal: serum creatinine ≤ 132 µmol/L. 6. Life expectancy of 6 months or more.

Exclusion criteria:

1. Patients who have previously received Biomodulin T. 2. Patients included in another clinical trial within 6 months prior to inclusion. 3. Patients who have been treated with others immunomodulators within 6 months prior to inclusion. 4. Patients with known hypersensitivity to any component of the formulation. 5. Pregnant or lactating patients. 6. Patients of child bearing age who are not using anadequate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tub alligation). In the case of male sex use of condoms while the treatment and/or vasectomylasts. 7. Patientswithacuteallergicstatesorhistory of severeallergicreactions. 8. Patients with uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and psychiatric illnesses that imply the incompetence of the subject. 9. Patients with malignant diseases at the time of inclusión or in the 5 years prior to inclusion, except cancer in situ. 10. Patients with Hepatitis B or C virus infection at the time of inclusion in thestudy. 11. Patients with opportunistic infection at the time of inclusion in the study.

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

198

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:

Rene

Last Name:

Rodriguez-Feo Cou

Specialty:

Specialist in Integral General Medicine. Master in infectious diseases.

Affiliation:

Provincial Health Office of Mayabeque.

Postal Address:

130 Street without number, between 47th and 65th, Chavez neighborhood, Jamaica, San Jose de las Lajas.

City:

Mayabeque

Country:

Cuba

Zip Code:

32700

Telephone:

+53- 47848426

Email :

renerf@infomed.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:

Suset

Last Name:

Rodriguez Chavez

Specialty:

BSc. Pharmaceutical Sciences, MSc. Clinical Pharmacy

Affiliation:

National Center of Bioproducts (BIOCEN)

Postal Address:

Beltran road, Km 1 ½ Bejucal.

City:

Mayabeque

Country:

Cuba

Zip Code:

32600

Telephone:

+53- 47682441

Email :

suset.rdguez@biocen.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:

RPCEC00000288

Date of Registration in Primary Registry:

15/08/2018

Record Verification Date:

2020/04/15

Next update date:

2021/04/15

Link to the spanish version:

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Evaluation of Biomodulin T® in patients with HIV/AIDS. Phase II/III.

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