Clinical Trials


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

This study has been completed
Astra USA

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: March 1996
History of Changes


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.

Condition Intervention Phase
Herpes Simplex
HIV Infections

Drug : Foscarnet sodium
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 12

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.



Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria
Concurrent Medication:

  • 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:
  • 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:
  • Intravenous foscarnet within 2 months prior to study entry.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002144


United States, California
CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States, 90095
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
South Miami Hosp
Miami, Florida, United States, 33143
United States, Illinois
Dr Thomas Klein
Chicago, Illinois, United States, 60610
United States, New York
Bellevue Hosp Ctr
New York, New York, United States, 10016
United States, Ohio
Univ Hosps of Cleveland
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Roger Williams Med Ctr
Providence, Rhode Island, United States, 02908
United States, Wisconsin
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Astra USA


Study Chair: Hardy WD
More Information

More Information

Responsible Party: Astra USA Identifier: NCT00002144   History of Changes  
Other Study ID Numbers: 240A  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Herpes Simplex
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
Herpes Simplex
Virus Diseases
Phosphonoacetic Acid processed this data on July 10, 2020
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