The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
2 other identifiers
interventional
12
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astra USAlead
Study Sites (8)
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
South Miami Hosp
Miami, Florida, 33143, United States
Dr Thomas Klein
Chicago, Illinois, 60610, United States
Bellevue Hosp Ctr
New York, New York, 10016, United States
Univ Hosps of Cleveland
Cleveland, Ohio, 44106, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Hardy D, Javaly K, Wohlfeiler M, Kalayjian R, Klein T, Bryson Y, Graford K, Martin-Munley S. Phase I, pilot study of the safety and efficacy of foscarnet (PFA) cream for treatment (Rx) of acyclovir-unresponsive (ACV-R) herpes simplex (HSV). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:83
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hardy WD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-03