TuberculosisNCT05100758
Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
A study testing Active Hexoses Correlated Compound in people with Tuberculosis and Human Immunodeficiency Virus, run by Hasanuddin University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Human Immunodeficiency Virus
- What is being tested?
- Active Hexoses Correlated Compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
- Not Pregnant
- Diagnosed with HIV
Who cannot join
- Patient with liver dysfunction
- Patient with drug-resistant
- Severe Malnutrition
- Refuse to be involved
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Labuang Baji General Hospital
Makassar, South Sulawesi, 90132
About this study
Official title: 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
Read more
Purposes
- To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV
- 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
- Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome
- Lower proinflammatory cytokines are observed in people who receive active compound
Read the 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
- 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
- Conditions
- Tuberculosis, Human Immunodeficiency Virus
- Being tested
- Active Hexoses Correlated Compound
- Keywords
- Active Hexose Correlated Compound, Tuberculosis-HIV, Cytokine, Sputum Conversion
- Medical subject headings
- Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Hexoses Correlated CompoundDietary supplement
Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.
| Study group | Role | What they receive |
|---|---|---|
| Active Hexose Correlated Compound | Experimental | The participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months Receives: Dietary Supplement: Active Hexoses Correlated Compound |
| Control Group | No intervention | Participant will be given only the tuberculosis and antiretroviral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+.
Measured: 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
Measured: Changes of number of active tuberculosis feature from baseline to 6 months
Interleukin 6 Level
Value of Interleukin 6 in blood Sample
Measured: Changes of Interleukin 6 Level from baseline to 6 months
Interleukin 10 Level
Value of Interleukin 10 in blood Sample
Measured: Changes of Interleukin 10 value from baseline to 6 months
Secondary outcomes (2)
Cluster Differentiation 4 (CD4) cells value
Cluster Differentiation 4 (CD4) cells value in blood sample
Measured: 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
Measured: Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will be given Active Hexose Correlated Compound as adjuvant and the comparison group will only receive the tuberculosis treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumi Herman, Hasanuddin University
- Investigators
- Djamaludin Ma'dolangan, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100758
- Sponsor's protocol ID
- 0307210724
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data including de-identified data and protocol
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.
PubMed 28440968Sun 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.
PubMed 19699163Terakawa 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.
PubMed 18791928
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Hexose Correlated Compound to Clinical and Immunological Response in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
- ClinicalTrials.gov ID
- NCT05100758
- Acronym / sponsor ID
- 0307210724
- Conditions
- Tuberculosis, Human Immunodeficiency Virus
- Keywords
- Active Hexose Correlated Compound, Tuberculosis-HIV, Cytokine, Sputum Conversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV
- 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
- Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group will be given Active Hexose Correlated Compound as adjuvant and the comparison group will only receive the tuberculosis treatment
| Arm | Type | Receives |
|---|---|---|
| Active Hexose Correlated Compound | Experimental | Dietary Supplement: Active Hexoses Correlated CompoundThe participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months |
| Control Group | No intervention | –Participant will be given only the tuberculosis and antiretroviral treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
- Not Pregnant
- Diagnosed with HIV
Key exclusion criteria (4 listed)
- Patient with liver dysfunction
- Patient with drug-resistant
- Severe Malnutrition
- Refuse to be involved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Hexoses Correlated CompoundActive Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids. | Dietary supplement | Active Hexose Correlated Compound |
Primary outcome
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+.
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
Interleukin 6 Level
Time frame: Changes of Interleukin 6 Level from baseline to 6 months
Value of Interleukin 6 in blood Sample
Interleukin 10 Level
Time frame: Changes of Interleukin 10 value from baseline to 6 months
Value of Interleukin 10 in blood Sample
2 secondary outcomes
Cluster Differentiation 4 (CD4) cells value
Time frame: Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months
Cluster Differentiation 8 (CD8) cells value
Time frame: Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- BackgroundMatar, 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: PubMed 28440968Suknikhom 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.
- Background: PubMed 19699163Sun 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.
- Background: PubMed 18791928Terakawa 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data including de-identified data and protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamaludin Ma'dolangan, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Hexoses Correlated Compound in people with Tuberculosis and Human Immunodeficiency Virus, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum Conversion Duration (time frame: six month after the intervention started). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100758, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.