The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
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|ClinicalTrials.gov Identifier: NCT00002144|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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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 or disease||Intervention/treatment||Phase|
|Herpes Simplex HIV Infections||Drug: Foscarnet sodium||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Official Title:||The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment|
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|Ages Eligible for Study:||13 Years and older (Child, Adult, Older Adult)|
|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.
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.
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.
- 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.
- Intravenous foscarnet within 2 months prior to study entry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Study Chair:||Hardy WD|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||March 1996|
Acquired Immunodeficiency Syndrome
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action