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

January 15, 2021 updated by: Judith A. Smith, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UTHealth Medical School at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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
AHCC supplementation x 6 months with Placebo x 6 months
Other Names:
  • active hexose correlated compound
Placebo Comparator: Group 2
Placebo once a day on an empty stomach x 12 months
Other: Placebo
Placebo supplementation x 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roche, COBAS HPV DNA Assay (Pleasanton, CA)
Time Frame: once every 3 months for 12 months up to 18 months
HPV DNA testing
once every 3 months for 12 months up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interferon beta
Time Frame: once every 3 months for 12 months up to 18 months
Evaluation of Interferon Beta level
once every 3 months for 12 months up to 18 months
Interferon gamma
Time Frame: once every 3 months for 12 months up to 18 months
Evaluation of Interferon gamma level
once every 3 months for 12 months up to 18 months
NK Cells
Time Frame: once every 3 months for 12 months up to 18 months
Evaluation of Natural Killer (NK) cells
once every 3 months for 12 months up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Study Chair: Judith A Smith, Pharm.D., UTTexas_Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-14-0866

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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