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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100758
• Other study ID #: 0307210724
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2021
• Source: Hasanuddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Active Hexoses Correlated Compound
Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.

Locations

Country	Name	City	State
Indonesia	Labuang Baji General Hospital	Makasar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Interleukin 6 Level	Value of Interleukin 6 in blood Sample	Changes of Interleukin 6 Level from baseline to 6 months
Primary	Interleukin 10 Level	Value of Interleukin 10 in blood Sample	Changes of Interleukin 10 value from baseline to 6 months
Secondary	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
Secondary	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