The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Launched by ASTRA USA · Aug 30, 2001
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect 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.
Gender
ALL
Eligibility 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.
About Astra Usa
Astra USA, a subsidiary of AstraZeneca, is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative medicines that address unmet medical needs across various therapeutic areas, including oncology, cardiovascular, and respiratory diseases. With a strong commitment to advancing healthcare, Astra USA leverages cutting-edge science and technology to deliver high-quality treatments and improve patient outcomes. The organization emphasizes collaboration with healthcare professionals, regulatory bodies, and patient communities to ensure the safety and efficacy of its clinical trials, ultimately striving to enhance the quality of life for patients globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Milwaukee, Wisconsin, United States
Providence, Rhode Island, United States
New York, New York, United States
Los Angeles, California, United States
Cleveland, Ohio, United States
Miami, Florida, United States
Chicago, Illinois, United States
Patients applied
Trial Officials
Hardy WD
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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