The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Completed · Phase 1
Conditions studied: Herpes Simplex, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002144
- Run by
- Astra USA
- People needed
- 12
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- CARE Ctr / UCLA Med Ctr — Los Angeles, California, United States
- George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
- South Miami Hosp — Miami, Florida, United States
- Dr Thomas Klein — Chicago, Illinois, United States
- Bellevue Hosp Ctr — New York, New York, United States
- Univ Hosps of Cleveland — Cleveland, Ohio, United States
- Roger Williams Med Ctr — Providence, Rhode Island, United States
- Milwaukee County Med Complex — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.