Phase 2
N=59
Treatment of Oral Warts in HIV+ Patients
Papillomatosis · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00454181 ↗Enrolled (actual)
59
Serious AEs
6.8%
Results posted
Jan 2011
Primary outcome: Primary: Change in Total Oral Mucosal Area Covered by Warts. — 11; 2 participants — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interferon-alpha (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Oral Mucosal Area Covered by Warts. |
11; 2 | 0.30 |
| SECONDARY Total Surface Area of the Lips Covered by Warts |
5; 0 | 0.26 |
| SECONDARY Subject Questionnaire Regarding Changes in Warts |
18; 4 | 0.50 |
| SECONDARY Subject Questionnaire Regarding Global Oral Changes |
14; 2 | 0.29 |
| SECONDARY Investigator Assessment Regarding Changes in Warts |
13; 5 | 0.74 |
| SECONDARY Investigator Assessment Regarding Global Oral Changes. |
9; 2 | .71 |
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 remission of their oral warts compared to subjects given placebo.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00454181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.