NCT05100758

Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection

Effect of Active Hexose Correlated Compound to Clinical and Immunological Response in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hasanuddin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background Active Hexose Correlated Compound is assumed to have a positive effect on immunity, including induce a phagocytic response, reduce tumor resistance, and cytokine response including interferon-gamma and interleukins. Tuberculosis patients with concurrent Human immunodeficiency Virus (HIV) might have benefit when receiving active hexose compound during tuberculosis treatment Purposes 1. To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV 2. To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant Methods A clinical trial involving patients with Tuberculosis-HIV infection Hypothesis 1. Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome 2. Lower proinflammatory cytokines are observed in people who receive active compound

Detailed description

Population : Lung Tuberculosis patient with HIV Infection Design : Double-Blind Randomized Control Trial at the outpatient setting Randomization Simple Randomization Proposed Number of participants : Using the difference between two independent means of duration to sputum conversion 1. Type 1 error 5% 2. Power of study 80% 3. Effect Size 0.5 4. Dropout rate 20% Total Participant 122 Proposed analysis 1. Time-to-event analysis using cox regression for the duration of sputum conversion and radiology resolution 2. Linear mixed model for continuous dependent variable

Conditions

• Tuberculosis
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Hexoses Correlated Compound	Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2021-10-29
• Last updated: 2021-10-29

Locations

1 site across 1 country: Indonesia