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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Roche, COBAS HPV DNA Assay (Pleasanton, CA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• 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.
排除标准
- •• 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)
结局指标
主要结局
Roche, COBAS HPV DNA Assay (Pleasanton, CA)
时间窗: once every 3 months for 12 months up to 18 months
HPV DNA testing
次要结局
- NK Cells(once every 3 months for 12 months up to 18 months)
- Interferon gamma(once every 3 months for 12 months up to 18 months)
- Interferon beta(once every 3 months for 12 months up to 18 months)
研究者
Judith A. Smith
Associate Professor & Director of WHIM Research Program
The University of Texas Health Science Center, Houston