Human Papilloma VirusAHCC4HPVNCT02405533
Phase II Evaluation of AHCC for the Eradication of HPV Infections
A study testing AHCC 3 grams once a day in people with Human Papilloma Virus and Dysplasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Dysplasia, CIN1
- What is being tested?
- AHCC 3 grams once a day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHealth Medical School at Houston
Houston, Texas, 77030
About this study
Official title: 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
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.
Read the 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
- Being tested
- AHCC 3 grams once a day, Placebo
- Keywords
- AHCC, nutritional supplement, HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHCC 3 grams once a dayDietary supplement
Also called active hexose correlated compound
AHCC supplementation x 6 months with Placebo x 6 months
PlaceboOther
Placebo supplementation x 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months. Receives: Dietary Supplement: AHCC 3 grams once a day |
| Group 2 | Placebo comparator | Placebo once a day on an empty stomach x 12 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roche, COBAS HPV DNA Assay (Pleasanton, CA)
HPV DNA testing
Measured: once every 3 months for 12 months up to 18 months
Secondary outcomes (3)
Interferon beta
Evaluation of Interferon Beta level
Measured: once every 3 months for 12 months up to 18 months
Interferon gamma
Evaluation of Interferon gamma level
Measured: once every 3 months for 12 months up to 18 months
NK Cells
Evaluation of Natural Killer (NK) cells
Measured: once every 3 months for 12 months up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith A. Smith, The University of Texas Health Science Center, Houston
- Investigators
- Judith A Smith, Pharm.D., Study chair, UTTexas_Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405533
- Sponsor's protocol ID
- HSC-MS-14-0866
- Acronym
- AHCC4HPV
- Status last verified
- Jan 2021
- First submitted
- 17 Mar 2015
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35814366
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02405533
- Acronym / sponsor ID
- AHCC4HPV / HSC-MS-14-0866
- Conditions
- Human Papilloma Virus, Dysplasia, CIN1, CIN2
- Keywords
- AHCC, nutritional supplement, HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: AHCC 3 grams once a dayAHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months. |
| Group 2 | Placebo comparator | Other: PlaceboPlacebo once a day on an empty stomach x 12 months |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • 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.
Key exclusion criteria (10 listed)
- • History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (> 140/90).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHCC 3 grams once a dayAlso: active hexose correlated compoundAHCC supplementation x 6 months with Placebo x 6 months | Dietary supplement | Group 1 |
| PlaceboPlacebo supplementation x 12 months | Other | Group 2 |
Primary outcome
Roche, COBAS HPV DNA Assay (Pleasanton, CA)
Time frame: once every 3 months for 12 months up to 18 months
HPV DNA testing
3 secondary outcomes
Interferon beta
Time frame: once every 3 months for 12 months up to 18 months
Interferon gamma
Time frame: once every 3 months for 12 months up to 18 months
NK Cells
Time frame: once every 3 months for 12 months up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 35814366Smith 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A Smith, Pharm.D. study chair
UTTexas_Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHCC 3 grams once a day in people with Human Papilloma Virus and Dysplasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roche, COBAS HPV DNA Assay (Pleasanton, CA) (time frame: once every 3 months for 12 months up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.