Phase II Evaluation of AHCC for the Eradication of HPV Infections

Human Papilloma Virus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405533
• Other study ID #: HSC-MS-14-0866
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: November 2019

Study information

• Verified date: January 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• CIN1
• CIN2
• Dysplasia
• Human Papilloma Virus
• Papilloma
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
United States	UTHealth Medical School at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roche, COBAS HPV DNA Assay (Pleasanton, CA)	HPV DNA testing	once every 3 months for 12 months up to 18 months
Secondary	Interferon beta	Evaluation of Interferon Beta level	once every 3 months for 12 months up to 18 months
Secondary	Interferon gamma	Evaluation of Interferon gamma level	once every 3 months for 12 months up to 18 months
Secondary	NK Cells	Evaluation of Natural Killer (NK) cells	once every 3 months for 12 months up to 18 months