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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 Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

2014-07-23 21:57:15 | BioPortfolio

Summary

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.

Description

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Herpes Simplex

Intervention

Cidofovir

Location

Los Angeles County - USC Med Ctr
Los Angeles
California
United States
90033

Status

Completed

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:57:15-0400

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