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	Treatment or Intervention	Phase
Herpes Simplex HIV Infections	Drug: Foscarnet sodium	Phase I

Further Study Details: 

Expected Total Enrollment:  12

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 above,  Genders Eligible for Study:  Both

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.

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

Study chairs or principal investigators

Hardy WD,  Study Chair

Study ID Numbers:  240A; 92-FT-57
Record last reviewed:  March 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002144
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08