Clinical trial NCT02405533: Phase II Evaluation of AHCC for the Eradication of HPV Infections
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
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Dysplasia
CIN1
CIN2
Keywords: AHCC
nutritional supplement
HPV
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Roche, COBAS HPV DNA Assay (Pleasanton, CA)
timeFrame: once every 3 months for 12 months up to 18 months
Secondary outcomes:
measure: Interferon beta
timeFrame: once every 3 months for 12 months up to 18 months
measure: Interferon gamma
timeFrame: once every 3 months for 12 months up to 18 months
measure: NK Cells
timeFrame: once every 3 months for 12 months up to 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: UTHealth Medical School at Houston
state: Texas
Study officials:
affiliation: UTTexas_Houston
name: Judith A Smith, Pharm.D.
role: STUDY_CHAIR
References:
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.