NCT02405533

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papilloma Virus
• Dysplasia
• CIN1
• CIN2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2015-04-01
• Last updated: 2021-01-20

Locations

1 site across 1 country: United States