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Completed

NCT Number: NCT05100758

Active Hexose Correlated Compound 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Labuang Baji General Hospital

Makassar, South Sulawesi, 90132, Indonesia

About this study

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

  • Type 1 error 5%
  • Power of study 80%
  • Effect Size 0.5
  • Dropout rate 20% Total Participant 122

Proposed analysis

  • Time-to-event analysis using cox regression for the duration of sputum conversion and radiology resolution
  • Linear mixed model for continuous dependent variable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Active Hexoses Correlated Compound

Dietary Supplement

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

Primary outcomes

  1. Sputum Conversion Duration

    Time frame: six month after the intervention started

    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+.

  2. Chest X-Ray Extension

    Time frame: Changes of number of active tuberculosis feature from baseline to 6 months

    Distribution of active tuberculosis feature in Chest X-Ray including number of consolidation and cavitation

  3. Interleukin 6 Level

    Time frame: Changes of Interleukin 6 Level from baseline to 6 months

    Value of Interleukin 6 in blood Sample

  4. Interleukin 10 Level

    Time frame: Changes of Interleukin 10 value from baseline to 6 months

    Value of Interleukin 10 in blood Sample

Secondary outcomes

  1. Cluster Differentiation 4 (CD4) cells value

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

    Cluster Differentiation 4 (CD4) cells value in blood sample

  2. Cluster Differentiation 8 (CD8) cells value

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

    Cluster Differentiation 8 (CD8) cells value in blood sample

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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