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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002144
• Other study ID #: 240A
• Secondary ID: 92-FT-57
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• HIV Infections
• Infection
• Virus Diseases

Intervention

Drug:
• Foscarnet sodium

Locations

Country	Name	City	State
United States	Dr Thomas Klein	Chicago	Illinois
United States	Univ Hosps of Cleveland	Cleveland	Ohio
United States	CARE Ctr / UCLA Med Ctr	Los Angeles	California
United States	South Miami Hosp	Miami	Florida
United States	Milwaukee County Med Complex	Milwaukee	Wisconsin
United States	Bellevue Hosp Ctr	New York	New York
United States	Roger Williams Med Ctr	Providence	Rhode Island
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Astra USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hardy D, Javaly K, Wohlfeiler M, Kalayjian R, Klein T, Bryson Y, Graford K, Martin-Munley S. Phase I, pilot study of the safety and efficacy of foscarnet (PFA) cream for treatment (Rx) of acyclovir-unresponsive (ACV-R) herpes simplex (HSV). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:83