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

Tuberculosis Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Tuberculosis

• NCT number: NCT05100758
• Study type: Interventional
• Source: Hasanuddin University
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Completion date: December 1, 2020