Phase II Evaluation of AHCC for the Eradication of HPV Infections

NCT02405533 | Completed

• 1 other identifier: HSC-MS-14-0866
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication persistent high risk HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment compared to placebo.

Conditions

Human Papilloma Virus; Dysplasia; CIN1; CIN2

Keywords

AHCC; nutritional supplement; HPV

Outcome Measures

Primary Outcomes (1)

• Roche, COBAS HPV DNA Assay (Pleasanton, CA)

  HPV DNA testing

  once every 3 months for 12 months up to 18 months

Secondary Outcomes (3)

• Interferon beta

  once every 3 months for 12 months up to 18 months

• Interferon gamma

  once every 3 months for 12 months up to 18 months

• NK Cells

  once every 3 months for 12 months up to 18 months

Study Arms (2)

Group 1

EXPERIMENTAL

AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.

Dietary Supplement: AHCC 3 grams once a day

Group 2

PLACEBO COMPARATOR

Placebo once a day on an empty stomach x 12 months

Other: Placebo

Interventions

AHCC 3 grams once a day DIETARY_SUPPLEMENT

AHCC supplementation x 6 months with Placebo x 6 months

Also known as: active hexose correlated compound

Group 1

Placebo OTHER

Placebo supplementation x 12 months

Group 2

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry.
• Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia
• greater than 6 months and no more than 18 months prior to study entry
• greater than 24 months prior to study entry.
• Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start.
• Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC \>/= 1,500 cells/mm3, platelets 100,000 \>/= cells/mm3; Creatinine clearance\>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase \</= 1.5 times normal.
• Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.

You may not qualify if:

• History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (\> 140/90).
• Women with a current or prior diagnosis of cancer
• Women with a current diagnosis of CIN3 cervical dysplasia
• Women that are pregnant or breast feeding.
• Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive
• Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures.
• Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants)
• Women that have taken AHCC within the past six months.
• Women currently taking other immune modulating nutritional supplements.
• Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UTHealth Medical School at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Active Hexose Correlated Compound

Study Officials

• Judith A Smith, Pharm.D.

  UTTexas_Houston

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Director of WHIM Research Program

Model Details: Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 1, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

US (1)