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| Descriptive Information Fields | |||||
| Brief Title † | The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment | ||||
| Official Title † | The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Herpes Simplex HIV Infections |
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| Intervention † | Drug: Foscarnet sodium | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 12 | ||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | 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:
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| Gender | Both | ||||
| Ages | 13 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002144 | ||||
| Organization ID | 240A | ||||
| Secondary IDs †† | 92-FT-57 | ||||
| Study Sponsor † | Astra USA | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | NIH AIDS Clinical Trials Information Service | ||||
| Verification Date | March 1996 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||