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

Astra USA

Status and phase: Completed; Phase 1

Conditions: Herpes Simplex; HIV Infections

Treatments: Drug: Foscarnet sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002144

92-FT-57

240A

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.