Phase II Evaluation of AHCC for the Eradication of HPV Infections

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2019

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.

Interventions

  • Dietary Supplement: AHCC 3 grams once a day
    • AHCC supplementation x 6 months with Placebo x 6 months
  • Other: Placebo
    • Placebo supplementation x 12 months

Arms, Groups and Cohorts

  • Experimental: Group 1
    • AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
  • Placebo Comparator: Group 2
    • Placebo once a day on an empty stomach x 12 months

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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)
  • Gender Eligibility: Female

    Minimum Age: 30 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • The University of Texas Health Science Center, Houston
    • Provider of Information About this Clinical Study
      • Principal Investigator: Judith A. Smith, Associate Professor & Director of WHIM Research Program – The University of Texas Health Science Center, Houston
    • Overall Official(s)
      • Judith A Smith, Pharm.D., Study Chair, UTTexas_Houston

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.