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

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

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

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Human Immunodeficiency Virus
• Intervention / Treatment: Dietary supplement: Active Hexoses Correlated 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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • South Sulawesi
    • Makasar, South Sulawesi, Indonesia, 90132
      • Labuang Baji General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Hexose Correlated Compound; The participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months	Dietary supplement: Active Hexoses Correlated Compound; Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.
No Intervention: Control Group; Participant will be given only the tuberculosis and antiretroviral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum Conversion Duration	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+.	six month after the intervention started
Chest X-Ray Extension	Distribution of active tuberculosis feature in Chest X-Ray including number of consolidation and cavitation	Changes of number of active tuberculosis feature from baseline to 6 months
Interleukin 6 Level	Value of Interleukin 6 in blood Sample	Changes of Interleukin 6 Level from baseline to 6 months
Interleukin 10 Level	Value of Interleukin 10 in blood Sample	Changes of Interleukin 10 value from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cluster Differentiation 4 (CD4) cells value	Cluster Differentiation 4 (CD4) cells value in blood sample	Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months
Cluster Differentiation 8 (CD8) cells value	Cluster Differentiation 8 (CD8) cells value in blood sample	Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Principal Investigator: Djamaludin Ma'dolangan, MD, Hasanuddin University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cytokine; Active Hexose Correlated Compound; Tuberculosis-HIV; Sputum Conversion
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Slow Virus Diseases; HIV Infections; Tuberculosis; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 0307210724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data including de-identified data and protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No