The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Foscarnet sodium
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
George Washington Univ Med Ctr
Washington D.C., United StatesSouth Miami Hosp
Miami, United StatesDr Thomas Klein
Chicago, United States