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

Phase 2

Recruiting

• Conditions: Human Immunodeficiency Virus; HIV; HIV Infections; Lentiviruses Infections; Retroviridae Infections; RNA Viruses Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

• Registration Number: RPCEC00000288
• Lead Sponsor: ational Center of Bioproducts (BIOCEN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-15
• Study Completion: 2022-01-31
• Results First Posted: 2023-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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).<br>