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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months. |
|
| Group 2 | Placebo Comparator | Placebo once a day on an empty stomach x 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHCC 3 grams once a day | Dietary Supplement | AHCC supplementation x 6 months with Placebo x 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Roche, COBAS HPV DNA Assay (Pleasanton, CA) | HPV DNA testing | once every 3 months for 12 months up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Interferon beta | Evaluation of Interferon Beta level | once every 3 months for 12 months up to 18 months |
| Interferon gamma | Evaluation of Interferon gamma level |
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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
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).
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Smith, Pharm.D. | UTTexas_Houston | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHealth Medical School at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35814366 | Derived | 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. |
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| ID | Term |
|---|---|
| C499366 | Active Hexose Correlated Compound |
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Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
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| Placebo | Other | Placebo supplementation x 12 months |
|
| once every 3 months for 12 months up to 18 months |
| NK Cells | Evaluation of Natural Killer (NK) cells | once every 3 months for 12 months up to 18 months |