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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

PRIMARY: To evaluate the clinical activity of foscarnet cream on the index lesion of mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients previously unresponsive to acyclovir treatment.

SECONDARY: To evaluate the clinical activity and virologic activity of foscarnet cream on all treated lesions in this patient population. To evaluate the local tolerance and side effects of treatment with foscarnet cream in this patient population.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astra USA
• Treatments: Acyclovir; Foscarnet; Phosphonoacetic Acid

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.