Clinical trial · Interventional
Treatment of Oral Warts in HIV+ Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Papillomatosis | Papillomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon-alpha | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IFN lozenges
- description
- 500 IU Interferon-alpha lozenges for oral dissolution
- interventionNames
- Drug: Interferon-alpha
- type
- PLACEBO_COMPARATOR
- label
- placebo lozenges
- description
- 200 mg lozenges containing anhydrous crystalline maltose
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Change in Total Oral Mucosal Area Covered by Warts.
- timeFrame
- 24 weeks, from baseline to the end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available