The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
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.
Drug : Foscarnet sodium
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:
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.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
- 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).
- Intravenous foscarnet within 2 months prior to study entry.
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
Previous participation in the study.
Contacts and LocationsChoosing 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 ClinicalTrials.gov identifier: NCT00002144
Locations Show More
|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 CollaboratorsAstra USA
|Study Chair:||Hardy WD|
|Responsible Party:||Astra USA|
|ClinicalTrials.gov 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:
ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.