The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment

Launched by ASTRA USA · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive topical applications of one percent foscarnet cream five times daily for up to 6 weeks; those who show no evidence of epithelialization of the index lesion after 3 or more weeks are removed from study and offered intravenous foscarnet. Patients who show a good response to topical foscarnet cream at the end of 6 weeks may continue receiving treatment at the discretion of the investigator.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Ganciclovir (provided drug was administered for at least 14 days prior to study entry, and the HSV isolate exhibits resistance against acyclovir).
• • Other medication considered necessary for patient's welfare, at the discretion of the investigator.
• Patients must have:
• • HIV infection or AIDS.
• • Mucocutaneous HSV infection with at least one clinically evaluable lesion.
• • Prior acyclovir without clinical benefit.
• • Life expectancy of at least 3 months.
• • Consent of parent or guardian if less than 18 years of age.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Known hypersensitivity to the study drug.
• • Any medical, psychiatric, or other condition that would preclude study compliance.
• • Incapable of self administration of medication or presence of a care provider administering medication.
• Concurrent Medication:
• Excluded:
• • Intravenous foscarnet for current episode of HSV.
• • Acyclovir, interferon, or any investigational drug that might have anti-HSV activity (e.g., 256U87, HPMPC, BVDaraU, trifluridine).
• Patients with the following prior condition are excluded:
• • Previous participation in the study.
• Prior Medication:
• Excluded:
• • Intravenous foscarnet within 2 months prior to study entry.