An interventional study of AHCC 3 grams once a day and Placebo in Human Papilloma Virus, Dysplasia and CIN1, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to female participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 50 is below the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (> 140/90).
AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
Dietary Supplement: AHCC 3 grams once a day
Placebo once a day on an empty stomach x 12 months
Other: Placebo
AHCC supplementation x 6 months with Placebo x 6 months
Also known as: active hexose correlated compound
Placebo supplementation x 12 months
Roche, COBAS HPV DNA Assay (Pleasanton, CA)
HPV DNA testing
Time frame: once every 3 months for 12 months up to 18 months
Interferon beta
Evaluation of Interferon Beta level
Time frame: once every 3 months for 12 months up to 18 months
Interferon gamma
Evaluation of Interferon gamma level
Time frame: once every 3 months for 12 months up to 18 months
NK Cells
Evaluation of Natural Killer (NK) cells
Time frame: once every 3 months for 12 months up to 18 months
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston