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

This study is currently recruiting participants.
Verified November 2016 by Judith A. Smith, The University of Texas Health Science Center, Houston
Sponsor:
ClinicalTrials.gov Identifier:
NCT02405533
First Posted: April 1, 2015
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Judith A. Smith, The University of Texas Health Science Center, Houston
March 17, 2015
April 1, 2015
November 10, 2016
March 2015
June 2018   (Final data collection date for primary outcome measure)
Cervista HPV High Risk Assay [Cervista,(Hologic, Inc., Bedford, MA) [ Time Frame: once every 3 months for 12 months up to 18 months ]
HPV testing
Same as current
Complete list of historical versions of study NCT02405533 on ClinicalTrials.gov Archive Site
Immune marker panel [ Time Frame: once every 3 months for 12 months up to 18 months ]
evaluation of selected immune markers
Same as current
Not Provided
Not Provided
 
Phase II Evaluation of AHCC for the Eradication of HPV Infections
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Human Papilloma Virus
  • Dysplasia
  • CIN1
  • CIN2
  • Dietary Supplement: AHCC 3 grams once a day
    AHCC supplementation x 6 months with Placebo x 6 months
    Other Name: active hexose correlated compound
  • Other: Placebo
    Placebo supplementation x 12 months
  • Experimental: Group 1
    AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
    Intervention: Dietary Supplement: AHCC 3 grams once a day
  • Placebo Comparator: Group 2
    Placebo once a day on an empty stomach x 12 months
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2018
June 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
30 Years and older   (Adult, Senior)
Yes
Contact: Judith A Smith 713-500-6408 Judith.Ann.Smith@uth.tmc.edu
United States
 
 
NCT02405533
HSC-MS-14_0866
No
Not Provided
Not Provided
Judith A. Smith, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Study Chair: Judith A Smith, Pharm.D. UTTexas_Houston
The University of Texas Health Science Center, Houston
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP