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

Hasanuddin University

Status: Completed

Conditions: Human Immunodeficiency Virus; Tuberculosis

Treatments: Dietary Supplement: Active Hexoses Correlated Compound

Study type: Interventional

Funder types: Other

Identifiers

NCT05100758

0307210724

Details and patient eligibility

About

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

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
2. Not Pregnant
3. Diagnosed with HIV

Exclusion criteria

1. Patient with liver dysfunction
2. Patient with drug-resistant
3. Severe Malnutrition
4. Refuse to be involved

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Active Hexose Correlated Compound

Experimental group

Description:

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

Treatment:

Dietary Supplement: Active Hexoses Correlated Compound

Control Group

No Intervention group

Description:

Participant will be given only the tuberculosis and antiretroviral treatment