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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex; HIV Infections

Intervention: Foscarnet sodium (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astra USA

Official(s) and/or principal investigator(s):
Hardy WD, Study Chair


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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Detailed 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.


Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

CARE Ctr / UCLA Med Ctr, Los Angeles, California 90095, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

South Miami Hosp, Miami, Florida 33143, United States

Dr Thomas Klein, Chicago, Illinois 60610, United States

Bellevue Hosp Ctr, New York, New York 10016, United States

Univ Hosps of Cleveland, Cleveland, Ohio 44106, United States

Roger Williams Med Ctr, Providence, Rhode Island 02908, United States

Milwaukee County Med Complex, Milwaukee, Wisconsin 53226, United States

Additional Information

Related publications:

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

Last updated: June 23, 2005

Page last updated: August 23, 2015

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