Clinical trial NCT05100758: Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
Official title: Effect of Active Hexose Correlated Compound to Clinical and Immunological Response in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Human Immunodeficiency Virus
Keywords: Active Hexose Correlated Compound
Tuberculosis-HIV
Cytokine
Sputum Conversion
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be given Active Hexose Correlated Compound as adjuvant and the comparison group will only receive the tuberculosis treatment
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Sputum Conversion Duration
timeFrame: six month after the intervention started
measure: Chest X-Ray Extension
timeFrame: Changes of number of active tuberculosis feature from baseline to 6 months
measure: Interleukin 6 Level
timeFrame: Changes of Interleukin 6 Level from baseline to 6 months
measure: Interleukin 10 Level
timeFrame: Changes of Interleukin 10 value from baseline to 6 months
Secondary outcomes:
measure: Cluster Differentiation 4 (CD4) cells value
timeFrame: Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months
measure: Cluster Differentiation 8 (CD8) cells value
timeFrame: Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months
Other outcomes:
Locations:
city: Makasar
country: Indonesia
facility: Labuang Baji General Hospital
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Djamaludin Ma'dolangan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matar, C., Graham, E. 2017. Immune Modulatory Function. Clinician's Guide To AHCC, Evidence-Based Nutritional Immunotherapy, Edited by Anil D.K, Philip, C and Toshinori Ito. P.54-61.
citation: Suknikhom W, Lertkhachonsuk R, Manchana T. The Effects of Active Hexose Correlated Compound (AHCC) on Levels of CD4+ and CD8+ in Patients with Epithelial Ovarian Cancer or Peritoneal Cancer Receiving Platinum Based Chemotherapy. Asian Pac J Cancer Prev. 2017 Mar 1;18(3):633-638. doi: 10.22034/APJCP.2017.18.3.633.
citation: Sun B, Wakame K, Sato E, Nishioka H, Aruoma OI, Fujii H. The effect of active hexose correlated compound in modulating cytosine arabinoside-induced hair loss, and 6-mercaptopurine- and methotrexate-induced liver injury in rodents. Cancer Epidemiol. 2009 Oct;33(3-4):293-9. doi: 10.1016/j.canep.2009.07.006. Epub 2009 Aug 20.
citation: Terakawa N, Matsui Y, Satoi S, Yanagimoto H, Takahashi K, Yamamoto T, Yamao J, Takai S, Kwon AH, Kamiyama Y. Immunological effect of active hexose correlated compound (AHCC) in healthy volunteers: a double-blind, placebo-controlled trial. Nutr Cancer. 2008;60(5):643-51. doi: 10.1080/01635580801993280.