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

NCT05100758 | Completed

• 1 other identifier: 0307210724
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV
2. 2.To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant
3. 3.Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome
4. 4.Lower proinflammatory cytokines are observed in people who receive active compound

Conditions

Tuberculosis; Human Immunodeficiency Virus

Keywords

Active Hexose Correlated Compound; Tuberculosis-HIV; Cytokine; Sputum Conversion

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Cluster Differentiation 4 (CD4) cells value

  Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months

• Cluster Differentiation 8 (CD8) cells value

  Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months

Study Arms (2)

Active Hexose Correlated Compound

EXPERIMENTAL

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

Dietary Supplement: Active Hexoses Correlated Compound

Control Group

NO INTERVENTION

Participant will be given only the tuberculosis and antiretroviral treatment

Interventions

Active Hexoses Correlated Compound DIETARY_SUPPLEMENT

Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.

Active Hexose Correlated Compound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
• Not Pregnant
• Diagnosed with HIV

You may not qualify if:

• Patient with liver dysfunction
• Patient with drug-resistant
• Severe Malnutrition
• Refuse to be involved

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Labuang Baji General Hospital

Makassar, South Sulawesi, 90132, Indonesia

Location

Related 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.

  BACKGROUND

• 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.

  PMID: 28440968 BACKGROUND

• 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.

  PMID: 19699163 BACKGROUND

• 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.

  PMID: 18791928 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Djamaludin Ma'dolangan, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator will be blinded from the allocation (not allowed to observe the allocation and intervention) and the outcome assessor will not be informed the code of allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: One group will be given Active Hexose Correlated Compound as adjuvant and the comparison group will only receive the tuberculosis treatment

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 29, 2021
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)