HPV InfectionNCT06752083
Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection
An observational study of HPV Infection, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
This is a retrospective, multicenter, observational study evaluating real-world HPV-DNA clearance in women with documented persistent high-risk HPV infection lasting at least six months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- AHCC® (Active Hexose Correlated Compound) and Gardasil 9®
- Type of treatment
- Vaccines
- How many people
- 289 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2023to 15 Dec 2024
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with documented persistent high-risk HPV infection for at least six months whose clinical data were retrospectively identified from medical records at multiple participating gynecology centers.
Who may be able to join
- Female participants aged 18 years or older.
- Documented persistent high-risk HPV infection for at least 6 continuous months, confirmed by consecutive HPV-DNA tests.
- Absence of high-grade cervical lesions (≤ CIN1).
- Availability of complete clinical records with evaluable HPV-DNA testing at baseline and follow-up.
- Documented management with AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination in routine clinical practice.
- No prior excisional or ablative treatment of the cervix (including conization or LEEP).
Who cannot join
- History of cervical excisional or ablative treatment (including conization or LEEP).
- Presence of high-grade cervical lesions (CIN2 or worse) or invasive cervical cancer.
- Incomplete clinical documentation or missing HPV follow-up data.
- Conditions known to significantly alter immune function, including ongoing immunosuppressive therapy, active autoimmune disease requiring systemic treatment, or documented immunodeficiency, when such information was available in medical records.
- Prior systemic antiviral or immunomodulatory therapy specifically aimed at HPV clearance during the observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of an AHCC®-Based Supplement (Lentinula Edodes) in Promoting Negativity of Persistent HPV Infection: A Retrospective Multicenter Clinical Study
This is a retrospective, multicenter, observational study evaluating real-world HPV-DNA clearance in women with documented persistent high-risk HPV infection lasting at least six months. Clinical data were retrospectively collected from medical records of women managed in routine practice with one of three strategies: AHCC® supplementation alone, nonavalent HPV vaccination alone, or the combination of AHCC® supplementation and nonavalent HPV vaccination. The primary objective is to assess HPV-DNA clearance at 4 and 6 months following treatment initiation.
Read the detailed description
This retrospective, multicenter, observational study evaluates HPV-DNA clearance in women with documented persistent high-risk HPV infection managed in routine clinical practice. Eligible participants had confirmed HPV-DNA positivity persisting for at least six months and no high-grade cervical lesions.
Clinical data were retrospectively collected from medical records from January 2023 to December 2024. Participants were categorized into three exposure groups based on treatments already received as part of standard care: AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination. No randomization or prospective treatment assignment was performed.
The primary outcome is HPV-DNA clearance, defined as conversion from HPV-DNA positive to negative status, assessed at 4 and 6 months after treatment initiation. Secondary outcomes include safety, tolerability, and treatment compliance based on routinely collected clinical data. This study reflects real-world clinical practice and was not designed as a randomized interventional trial.
- Conditions
- HPV Infection
- Being tested
- AHCC® (Active Hexose Correlated Compound), Gardasil 9®
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHCC® (Active Hexose Correlated Compound)Dietary supplement
Also called Lentinula edodes supplement, Papion®
AHCC® supplementation previously prescribed as part of routine clinical care. Information on dosage and duration was retrospectively collected from medical records.
Gardasil 9®Biological
Nonavalent HPV vaccination previously administered as part of routine clinical care. Vaccination status was retrospectively obtained from medical records.
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated with AHCC® Supplement | Women previously managed in routine clinical practice with AHCC® supplementation alone for persistent HPV infection. Participants had not received HPV vaccination prior to treatment. Clinical data were retrospectively collected from medical records to evaluate HPV-DNA clearance following this real-world management strategy. Receives: Dietary Supplement: AHCC® (Active Hexose Correlated Compound) | |
| Vaccinated with AHCC® Supplement | Women previously managed in routine clinical practice with combined AHCC® supplementation and nonavalent HPV vaccination for persistent HPV infection. Treatments were prescribed as part of standard care. Clinical data were retrospectively collected to assess HPV-DNA clearance following combined real-world exposure. Receives: Dietary Supplement: AHCC® (Active Hexose Correlated Compound); Biological: Gardasil 9® | |
| Vaccinated Only | Women previously managed in routine clinical practice with nonavalent HPV vaccination alone for persistent HPV infection. No AHCC® supplementation was used. Clinical data were retrospectively collected to assess HPV-DNA clearance following vaccination as standard care. Receives: Biological: Gardasil 9® |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV-DNA Clearance Rate
Proportion of participants achieving HPV-DNA negativity, defined as conversion from HPV-DNA positive to negative status based on clinically validated HPV-DNA testing.
Measured: 4 months and 6 months
Secondary outcomes (1)
Safety and Tolerability
Description of adverse events, tolerability, and treatment compliance based on retrospective review of routinely collected clinical records. Adverse events were classified according to CTCAE version 5.0 and analyzed descriptively.
Measured: 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start2 Jan 2023
- Primary completion30 Jun 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752083
- Sponsor's protocol ID
- 117_22.112024_Papion®
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gau VL, Benninger MS. Potential Role for Active Hexose Correlated Compound (AHCC) in Treatment of Recurrent Respiratory Papillomatosis. J Voice. 2022 Jul;36(4):441-442. doi: 10.1016/j.jvoice.2022.05.004. Epub 2022 Jun 27. No abstract available.
PubMed 35773058Smith JA, Mathew L, Gaikwad A, Rech B, Burney MN, Faro JP, Lucci JA 3rd, Bai Y, Olsen RJ, Byrd TT. From Bench to Bedside: Evaluation of AHCC Supplementation to Modulate the Host Immunity to Clear High-Risk Human Papillomavirus Infections. Front Oncol. 2019 Mar 20;9:173. doi: 10.3389/fonc.2019.00173. eCollection 2019.
PubMed 30949451Smith JA, Gaikwad AA, Mathew L, Rech B, Faro JP, Lucci JA 3rd, Bai Y, Olsen RJ, Byrd TT. AHCC(R) Supplementation to Support Immune Function to Clear Persistent Human Papillomavirus Infections. Front Oncol. 2022 Jun 22;12:881902. doi: 10.3389/fonc.2022.881902. eCollection 2022.
PubMed 35814366
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an AHCC®-Based Supplement (Lentinula Edodes) in Promoting Negativity of Persistent HPV Infection: A Retrospective Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06752083
- Acronym / sponsor ID
- 117_22.112024_Papion®
- Conditions
- HPV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 30 Dec 2024 (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.
This is a retrospective, multicenter, observational study evaluating real-world HPV-DNA clearance in women with documented persistent high-risk HPV infection lasting at least six months. Clinical data were retrospectively collected from medical records of women managed in routine practice with one of three strategies: AHCC® supplementation alone, nonavalent HPV vaccination alone, or the combination of AHCC® supplementation and nonavalent HPV vaccination. The primary objective is to assess HPV-DNA clearance at 4 and 6 months following treatment initiation.
Detailed description
This retrospective, multicenter, observational study evaluates HPV-DNA clearance in women with documented persistent high-risk HPV infection managed in routine clinical practice. Eligible participants had confirmed HPV-DNA positivity persisting for at least six months and no high-grade cervical lesions.
Clinical data were retrospectively collected from medical records from January 2023 to December 2024. Participants were categorized into three exposure groups based on treatments already received as part of standard care: AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination. No randomization or prospective treatment assignment was performed.
The primary outcome is HPV-DNA clearance, defined as conversion from HPV-DNA positive to negative status, assessed at 4 and 6 months after treatment initiation. Secondary outcomes include safety, tolerability, and treatment compliance based on routinely collected clinical data. This study reflects real-world clinical practice and was not designed as a randomized interventional trial.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated with AHCC® Supplement | – | Dietary Supplement: AHCC® (Active Hexose Correlated Compound)Women previously managed in routine clinical practice with AHCC® supplementation alone for persistent HPV infection. Participants had not received HPV vaccination prior to treatment. Clinical data were retrospectively collected from medical records to evaluate HPV-DNA clearance following this real-world management strategy. |
| Vaccinated with AHCC® Supplement | – | Dietary Supplement: AHCC® (Active Hexose Correlated Compound), Biological: Gardasil 9®Women previously managed in routine clinical practice with combined AHCC® supplementation and nonavalent HPV vaccination for persistent HPV infection. Treatments were prescribed as part of standard care. Clinical data were retrospectively collected to assess HPV-DNA clearance following combined real-world exposure. |
| Vaccinated Only | – | Biological: Gardasil 9®Women previously managed in routine clinical practice with nonavalent HPV vaccination alone for persistent HPV infection. No AHCC® supplementation was used. Clinical data were retrospectively collected to assess HPV-DNA clearance following vaccination as standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with documented persistent high-risk HPV infection for at least six months whose clinical data were retrospectively identified from medical records at multiple participating gynecology centers.
Key inclusion criteria (6 listed)
- Female participants aged 18 years or older.
- Documented persistent high-risk HPV infection for at least 6 continuous months, confirmed by consecutive HPV-DNA tests.
- Absence of high-grade cervical lesions (≤ CIN1).
- Availability of complete clinical records with evaluable HPV-DNA testing at baseline and follow-up.
- Documented management with AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination in routine clinical practice.
Key exclusion criteria (5 listed)
- History of cervical excisional or ablative treatment (including conization or LEEP).
- Presence of high-grade cervical lesions (CIN2 or worse) or invasive cervical cancer.
- Incomplete clinical documentation or missing HPV follow-up data.
- Conditions known to significantly alter immune function, including ongoing immunosuppressive therapy, active autoimmune disease requiring systemic treatment, or documented immunodeficiency, when such information was available in medical records.
- Prior systemic antiviral or immunomodulatory therapy specifically aimed at HPV clearance during the observation period.
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 |
|---|---|---|
| AHCC® (Active Hexose Correlated Compound)Also: Lentinula edodes supplement, Papion®AHCC® supplementation previously prescribed as part of routine clinical care. Information on dosage and duration was retrospectively collected from medical records. | Dietary supplement | Unvaccinated with AHCC® Supplement, Vaccinated with AHCC® Supplement |
| Gardasil 9®Nonavalent HPV vaccination previously administered as part of routine clinical care. Vaccination status was retrospectively obtained from medical records. | Biological | Vaccinated Only, Vaccinated with AHCC® Supplement |
Primary outcome
HPV-DNA Clearance Rate
Time frame: 4 months and 6 months
Proportion of participants achieving HPV-DNA negativity, defined as conversion from HPV-DNA positive to negative status based on clinically validated HPV-DNA testing.
1 secondary outcome
Safety and Tolerability
Time frame: 4 months and 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 28 Jan 2026.
- Background: PubMed 35773058Gau VL, Benninger MS. Potential Role for Active Hexose Correlated Compound (AHCC) in Treatment of Recurrent Respiratory Papillomatosis. J Voice. 2022 Jul;36(4):441-442. doi: 10.1016/j.jvoice.2022.05.004. Epub 2022 Jun 27. No abstract available.
- Background: PubMed 30949451Smith JA, Mathew L, Gaikwad A, Rech B, Burney MN, Faro JP, Lucci JA 3rd, Bai Y, Olsen RJ, Byrd TT. From Bench to Bedside: Evaluation of AHCC Supplementation to Modulate the Host Immunity to Clear High-Risk Human Papillomavirus Infections. Front Oncol. 2019 Mar 20;9:173. doi: 10.3389/fonc.2019.00173. eCollection 2019.
- Background: PubMed 35814366Smith JA, Gaikwad AA, Mathew L, Rech B, Faro JP, Lucci JA 3rd, Bai Y, Olsen RJ, Byrd TT. AHCC(R) Supplementation to Support Immune Function to Clear Persistent Human Papillomavirus Infections. Front Oncol. 2022 Jun 22;12:881902. doi: 10.3389/fonc.2022.881902. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
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 6 inclusion and 5 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 28 Jan 2026. 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 Italy. 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?
HPV-DNA Clearance Rate (time frame: 4 months and 6 months). 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 NCT06752083, which also lists 3 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 28 Jan 2026.