A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Condyloma Acuminatum in Patients With HIV Infection
Four groups of 10 patients each receive topical HPMPC at 0.3 percent concentration for 5 or
10 days total or 1.0 percent concentration for 5 or 10 days total, followed by 2 weeks of
rest. When six patients at a given dose and schedule have completed treatment and follow-up
without significant toxicity, subsequent patients are entered at the next higher dose level.
Patients are evaluated twice weekly during treatment and once weekly during the rest period.
HPMPC may be extended for up to two additional courses in patients who experience no
significant toxicity.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Food and Drug Administration
219A
NCT00002327
Name | Location |
---|---|
Univ of Utah School of Medicine | Salt Lake City, Utah 84132 |
Bronx-Lebanon Hosp Ctr | Bronx, New York 10453 |
Houston Clinical Research Network | Houston, Texas 77266 |
East Bay AIDS Ctr | Berkeley, California 94705 |
Univ California San Francisco | San Francisco, California 941430316 |
City and County of Denver / Dept of Health & Hosps | Denver, Colorado 802044507 |
Univ of Rochester Med Ctr | Rochester, New York 14642 |
Dr Brad Bowden | Houston, Texas 77027 |
Dr Stephen Tyring | Nassau Bay, Texas 77058 |
Univ of Washington / Viral Disease Clinic | Seattle, Washington 98122 |
Pacific Med Ctr | Seattle, Washington 98144 |