CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Interferon-alpha +1 moredrug
Likely dose
Interferon-alpha 500 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00454181
NCT00454181Phase 2Completed
CompareCT.gov

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

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.·interventional·Posted Mar 30, 2007·Updated Sep 16, 2011

In Brief

A Phase 2 clinical trial evaluating Interferon-alpha and placebo for Papillomatosis and HIV Infections. Completed, enrolled 59 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomatosis, HIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2007
Enrollment StartFeb 1, 2007
Primary CompletionSep 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.3 years ago

Interventions

Interferon-alphadrug

500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks

placeboother

200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks