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| Sponsored by: |
Astra USA |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002144 |
Purpose
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 | Intervention | Phase |
|
Herpes Simplex HIV Infections |
Drug: Foscarnet sodium |
Phase I |
| MedlinePlus related topics: | AIDS Herpes Simplex |
| ChemIDplus related topics: | Acyclovir Acyclovir sodium Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| Official Title: | The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment |
| Estimated Enrollment: | 12 |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
Previous participation in the study.
Prior Medication:
Excluded:
Contacts and Locations| 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 | |||||
| Astra USA |
| Study Chair: | Hardy WD |
More Information
| 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 |
| Study ID Numbers: | 240A, 92-FT-57 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002144 |
| Health Authority: | United States: Food and Drug Administration |
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