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Phase II Evaluation of AHCC for the Eradication of HPV Infections (AHCC4HPV)

Primary Purpose

Human Papilloma Virus, Dysplasia, CIN1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AHCC 3 grams once a day
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Papilloma Virus focused on measuring AHCC, nutritional supplement, HPV

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • • 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

      • 1 greater than 6 months and no more than 18 months prior to study entry
      • 1 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.

Exclusion Criteria:

  • • 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)

Sites / Locations

  • UTHealth Medical School at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

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

Placebo once a day on an empty stomach x 12 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Interferon beta
Evaluation of Interferon Beta level
Interferon gamma
Evaluation of Interferon gamma level
NK Cells
Evaluation of Natural Killer (NK) cells

Full Information

First Posted
March 17, 2015
Last Updated
January 15, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02405533
Brief Title
Phase II Evaluation of AHCC for the Eradication of HPV Infections
Acronym
AHCC4HPV
Official Title
Phase II Randomized, Double-blind, Placebo-controlled Evaluation of AHCC (Active Hexose Correlated Compound) for the Eradication of HPV Infections in Women With HPV Positive Pap Smears
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication 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 for Group 1. We will follow all patients for at least 12 months and up to 30 months depending on success of achieving a negative HPV testing results. After receiving AHCC 3 grams x 6 months if positive at the end of 12 months of study treatment, they are considered a treatment failure. If negative after completion of 6 months of AHCC supplementation + 6 months of placebo, they will continue on study for another six months (2 visits) to confirm they remain HPV negative and durable response. Group 2 will serve as untreated control for all time points (end of supplementation, then 6, 9, and 12 months post end of AHCC supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, Dysplasia, CIN1, CIN2
Keywords
AHCC, nutritional supplement, HPV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo once a day on an empty stomach x 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
AHCC 3 grams once a day
Other Intervention Name(s)
active hexose correlated compound
Intervention Description
AHCC supplementation x 6 months with Placebo x 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo supplementation x 12 months
Primary Outcome Measure Information:
Title
Roche, COBAS HPV DNA Assay (Pleasanton, CA)
Description
HPV DNA testing
Time Frame
once every 3 months for 12 months up to 18 months
Secondary Outcome Measure Information:
Title
Interferon beta
Description
Evaluation of Interferon Beta level
Time Frame
once every 3 months for 12 months up to 18 months
Title
Interferon gamma
Description
Evaluation of Interferon gamma level
Time Frame
once every 3 months for 12 months up to 18 months
Title
NK Cells
Description
Evaluation of Natural Killer (NK) cells
Time Frame
once every 3 months for 12 months up to 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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 1 greater than 6 months and no more than 18 months prior to study entry 1 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. Exclusion Criteria: • 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith A Smith, Pharm.D.
Organizational Affiliation
UTTexas_Houston
Official's Role
Study Chair
Facility Information:
Facility Name
UTHealth Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35814366
Citation
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.
Results Reference
derived

Learn more about this trial

Phase II Evaluation of AHCC for the Eradication of HPV Infections

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