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.

ational Center of Bioproducts (BIOCEN)0 个研究点目标入组 198 人开始时间: 2018年8月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

ational Center of Bioproducts (BIOCEN)