PapillomatosisPhase 2NCT00454181
Treatment of Oral Warts in HIV+ Patients
A Phase 2 study testing Interferon-alpha in people with Papillomatosis and HIV Infections, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 12 sites in United States.
Trial summary
This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults. The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillomatosis, HIV Infections
- What is being tested?
- Interferon-alpha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2007to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have tested positive for HIV.
- Must have two or more warts inside the mouth.
- Must be receiving a standard course of anti-retroviral therapy (HAART).
Who cannot join
- Must not be receiving oral or injected steroids.
- Must not be taking other drugs for treatment of oral warts.
- Must not have other active HIV-related opportunistic infections.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Medical College of Georgia School of Dentistry
Augusta, Georgia, 30912-1241
University of Maryland Baltimore Dental School
Baltimore, Maryland, 21201
Division of Oral Medicine and Dentistry, Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Illinois at Chicago, College of Dentistry
Chicago, Illinois, 60612
Baylor College of Dentistry
Dallas, Texas, 75246
Nova Southeastern University College of Dental Medicine
Fort Lauderdale, Florida, 33328-2018
University of Kentucky College of Dentistry
Lexington, Kentucky, 40536-0297
New York University College of Dentistry
New York, New York, 10010
UMDNJ - New Jersey Dental School
Newark, New Jersey, 07108
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
University of California, School of Dentistry
San Francisco, California, 94143
About this study
Official title: Evaluation of Natural Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-seropositive Subjects Receiving Combination Anti-retroviral Therapy: A Phase 2 Clinical Trial
This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults.
The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.
Read the detailed description
Human papilloma virus (HPV) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with HIV. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can reduce or eliminate these warts in HIV+ subjects who are receiving combination anti-retroviral therapy (HAART). All potential subjects will have their warts examined and measured at a screening visit. A small amount of one wart (i.e. a biopsy) will be removed for microscopic evaluation to confirm HPV infection and a small amount of blood will be collected for testing. Subjects that qualify for entry will return for a baseline visit at which they will be randomized to active or placebo treatment for 24 weeks. Three out of four subjects will receive active treatment in this study. Subjects must return to the clinic every 6 weeks during treatment to have their warts re-examined. At these follow-up visits, subjects will be asked to complete a brief questionnaire regarding any perceived changes in their warts and their overall mouth condition. A small amount of blood will be taken at the final study visit at week 24 to assess the safety of the interferon lozenges.
- Conditions
- Papillomatosis, HIV Infections
- Being tested
- Interferon-alpha, placebo
- Keywords
- human immunodeficiency virus, human papilloma virus, warts, oral, papillomatosis, treatment experienced
- Medical subject headings
- Papilloma, HIV Infections, Acquired Immunodeficiency Syndrome, Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-alphaDrug
Also called Veldona, IFN-alpha lozenge, low dose IFN lozenge
500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks
placeboOther
Also called maltose, sugar pill
200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| IFN lozenges | Experimental | 500 IU Interferon-alpha lozenges for oral dissolution Receives: Drug: Interferon-alpha |
| placebo lozenges | Placebo comparator | 200 mg lozenges containing anhydrous crystalline maltose Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Oral Mucosal Area Covered by Warts.
Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area
Measured: 24 weeks, from baseline to the end of treatment
Secondary outcomes (5)
Total Surface Area of the Lips Covered by Warts
Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area
Measured: 24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Changes in Warts
Number of subjects reporting change in oral warts from baseline to week 24 as "better." Scale was subjective with 3 choices: "better," "worse," or "unchanged."
Measured: 24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Global Oral Changes
Number of subjects reporting change in global oral health from baseline to week 24 as "better." Scale was subjective with 3 choices: "better," "worse," or "unchanged."
Measured: 24 weeks, from baseline to end of treatment
Investigator Assessment Regarding Changes in Warts
Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: "improved," "worsened," or "unchanged."
Measured: 24 weeks, from baseline to the end of treatment
Investigator Assessment Regarding Global Oral Changes.
Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: "improved," "worsened," or "unchanged."
Measured: 24 weeks, from baseline to the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PapillomatosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah Greenspan, BDS, DSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454181
- Sponsor's protocol ID
- 03HUHI19
- Status last verified
- Sep 2011
- First submitted
- 29 Mar 2007
- Last updated
- 16 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Natural Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-seropositive Subjects Receiving Combination Anti-retroviral Therapy: A Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT00454181
- Acronym / sponsor ID
- 03HUHI19
- Conditions
- Papillomatosis, HIV Infections
- Keywords
- human immunodeficiency virus, human papilloma virus, warts, oral, papillomatosis, treatment experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Posted 13 Jan 2011
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 study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults.
The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.
Detailed description
Human papilloma virus (HPV) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with HIV. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can reduce or eliminate these warts in HIV+ subjects who are receiving combination anti-retroviral therapy (HAART). All potential subjects will have their warts examined and measured at a screening visit. A small amount of one wart (i.e. a biopsy) will be removed for microscopic evaluation to confirm HPV infection and a small amount of blood will be collected for testing. Subjects that qualify for entry will return for a baseline visit at which they will be randomized to active or placebo treatment for 24 weeks. Three out of four subjects will receive active treatment in this study. Subjects must return to the clinic every 6 weeks during treatment to have their warts re-examined. At these follow-up visits, subjects will be asked to complete a brief questionnaire regarding any perceived changes in their warts and their overall mouth condition. A small amount of blood will be taken at the final study visit at week 24 to assess the safety of the interferon lozenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFN lozenges | Experimental | Drug: Interferon-alpha500 IU Interferon-alpha lozenges for oral dissolution |
| placebo lozenges | Placebo comparator | Other: placebo200 mg lozenges containing anhydrous crystalline maltose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have tested positive for HIV.
- Must have two or more warts inside the mouth.
- Must be receiving a standard course of anti-retroviral therapy (HAART).
Key exclusion criteria (3 listed)
- Must not be receiving oral or injected steroids.
- Must not be taking other drugs for treatment of oral warts.
- Must not have other active HIV-related opportunistic infections.
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 |
|---|---|---|
| Interferon-alphaAlso: Veldona, IFN-alpha lozenge, low dose IFN lozenge500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks | Drug | IFN lozenges |
| placeboAlso: maltose, sugar pill200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks | Other | placebo lozenges |
Primary outcome
Change in Total Oral Mucosal Area Covered by Warts.
Time frame: 24 weeks, from baseline to the end of treatment
Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area
5 secondary outcomes
Total Surface Area of the Lips Covered by Warts
Time frame: 24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Changes in Warts
Time frame: 24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Global Oral Changes
Time frame: 24 weeks, from baseline to end of treatment
Investigator Assessment Regarding Changes in Warts
Time frame: 24 weeks, from baseline to the end of treatment
Investigator Assessment Regarding Global Oral Changes.
Time frame: 24 weeks, from baseline to the end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deborah Greenspan, BDS, DSc principal investigator
University of California, San Francisco
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon-alpha in people with Papillomatosis and HIV Infections, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 12 sites 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 3 inclusion and 3 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 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Oral Mucosal Area Covered by Warts. (time frame: 24 weeks, from baseline to the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2011.