Human Immunodeficiency Virus
Conditions
Interventions
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
Injections, Intramuscular Biomodulin T
Sponsors
National Center of Bioproducts (BIOCEN)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactRene Rodriguez-Feo Cou
Provincial Health Office of Mayabeque.
Outcome results
None listed