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

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 To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV 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 Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome Lower proinflammatory cytokines are observed in people who receive active compound

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 Type 1 error 5% Power of study 80% Effect Size 0.5 Dropout rate 20% Total Participant 122 Proposed analysis Time-to-event analysis using cox regression for the duration of sputum conversion and radiology resolution Linear mixed model for continuous dependent variable

One group will be given Active Hexose Correlated Compound as adjuvant and the comparison group will only receive the tuberculosis treatment

Investigator will be blinded from the allocation (not allowed to observe the allocation and intervention) and the outcome assessor will not be informed the code of allocation

The participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months

Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.

Sputum conversion duration defined as the duration to change positive result in sputum smear into negative results. The sputum smear level using Ziehl Neelsen ranging from Negative to 3+.

Distribution of active tuberculosis feature in Chest X-Ray including number of consolidation and cavitation

Inclusion Criteria: Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment Not Pregnant Diagnosed with HIV Exclusion Criteria: Patient with liver dysfunction Patient with drug-resistant Severe Malnutrition Refuse to be involved

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