ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment

This study has been completed.
Study NCT00002144.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by

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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Herpes Simplex
HIV Infections
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:

  • 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.
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 
Study Chair:     Hardy WD        
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers