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

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.