Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
- Conditions
- TuberculosisHuman Immunodeficiency Virus
- Interventions
- Dietary Supplement: Active Hexoses Correlated Compound
- Registration Number
- NCT05100758
- Lead Sponsor
- Hasanuddin University
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
- Not Pregnant
- Diagnosed with HIV
- Patient with liver dysfunction
- Patient with drug-resistant
- Severe Malnutrition
- Refuse to be involved
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Hexose Correlated Compound Active Hexoses Correlated Compound The participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months
- Primary Outcome Measures
Name Time Method Sputum Conversion Duration six month after the intervention started 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+.
Chest X-Ray Extension Changes of number of active tuberculosis feature from baseline to 6 months Distribution of active tuberculosis feature in Chest X-Ray including number of consolidation and cavitation
Interleukin 6 Level Changes of Interleukin 6 Level from baseline to 6 months Value of Interleukin 6 in blood Sample
Interleukin 10 Level Changes of Interleukin 10 value from baseline to 6 months Value of Interleukin 10 in blood Sample
- Secondary Outcome Measures
Name Time Method Cluster Differentiation 8 (CD8) cells value Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months Cluster Differentiation 8 (CD8) cells value in blood sample
Cluster Differentiation 4 (CD4) cells value Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months Cluster Differentiation 4 (CD4) cells value in blood sample
Trial Locations
- Locations (1)
Labuang Baji General Hospital
🇮🇩Makasar, South Sulawesi, Indonesia