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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Tuberculosis, Human Immunodeficiency Virus

Intervention / Treatment
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* Dietary Supplement: Active Hexoses Correlated Compound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will be given Active Hexose Correlated Compound as adjuvant and the comparison group will only receive the tuberculosis treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Hexose Correlated Compound<br>The participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months | Dietary Supplement: Active Hexoses Correlated Compound<br>* Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.<br>|
| No Intervention: Control Group<br>Participant will be given only the tuberculosis and antiretroviral treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Conversion Duration | 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+. | six month after the intervention started | 
| Chest X-Ray Extension | Distribution of active tuberculosis feature in Chest X-Ray including number of consolidation and cavitation | Changes of number of active tuberculosis feature from baseline to 6 months | 
| Interleukin 6 Level | Value of Interleukin 6 in blood Sample | Changes of Interleukin 6 Level from baseline to 6 months | 
| Interleukin 10 Level | Value of Interleukin 10 in blood Sample | Changes of Interleukin 10 value from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cluster Differentiation 4 (CD4) cells value | Cluster Differentiation 4 (CD4) cells value in blood sample | Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months | 
| Cluster Differentiation 8 (CD8) cells value | Cluster Differentiation 8 (CD8) cells value in blood sample | Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Hexose Correlated Compound, Tuberculosis-HIV, Cytokine, Sputum Conversion