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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.

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   

U.S. FDA Resources

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   12

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002144

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

Sponsors and Collaborators
Astra USA

Investigators
Study Chair:     Hardy WD    
  More Information

Publications:
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

Keywords provided by NIH AIDS Clinical Trials Information Service:
Herpes Simplex  
Foscarnet  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Herpes Simplex
Phosphonoacetic Acid
Sexually Transmitted Diseases, Viral
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Foscarnet
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Skin Diseases, Viral
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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