Phase II Evaluation of AHCC for the Eradication of HPV Infections

Completed · Not applicable · Has a placebo group

Conditions studied: Human Papilloma Virus, Dysplasia, CIN1, CIN2

In brief

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.

Key facts

Study ID

NCT02405533

Run by

The University of Texas Health Science Center, Houston

People needed

50

Starts

2015-04-01

Expected to finish

2019-11-01

Last updated by the study team

2021-01-20

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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)

Where it is running

• UTHealth Medical School at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.