Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection

NCT06752083 | Completed DMC

• 1 other identifier: 117_22.112024_Papion®
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months and 6 months

Secondary Outcomes (1)

• Safety and Tolerability

  4 months and 6 months

Study Arms (3)

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.

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.

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.

Biological: Gardasil 9®

Interventions

Gardasil 9® BIOLOGICAL

Nonavalent HPV vaccination previously administered as part of routine clinical care. Vaccination status was retrospectively obtained from medical records.

Vaccinated Only; Vaccinated with AHCC® Supplement

AHCC® (Active Hexose Correlated Compound) DIETARY_SUPPLEMENT

AHCC® supplementation previously prescribed as part of routine clinical care. Information on dosage and duration was retrospectively collected from medical records.

Also known as: Lentinula edodes supplement, Papion®

Unvaccinated with AHCC® Supplement; Vaccinated with AHCC® Supplement

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This retrospective study includes only female patients because cervical HPV infection and related clinical outcomes are specific to female reproductive anatomy. Sex was determined from routinely collected medical record data.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (1)

University of Insubria

Varese, Italy

Location

Related Publications (3)

• 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.

  PMID: 35773058 BACKGROUND

• Smith 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.

  PMID: 30949451 BACKGROUND

• Smith 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.

  PMID: 35814366 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Active Hexose Correlated Compound; Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: January 2, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 15, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)