Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT05100758
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2021-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
Sponsor:
Hasanuddin University
Organization:
Study Overview
Official Title:
Effect of Active Hexose Correlated Compound to Clinical and Immunological Response in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: