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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

NCT ID: NCT00002144

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Herpes Simplex HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Foscarnet sodium

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astra USA

INDUSTRY

Sponsor Role lead

Principal Investigators

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Hardy WD

Role: STUDY_CHAIR

Locations

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CARE Ctr / UCLA Med Ctr

Los Angeles, California, United States

Site Status

George Washington Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

South Miami Hosp

Miami, Florida, United States

Site Status

Dr Thomas Klein

Chicago, Illinois, United States

Site Status

Bellevue Hosp Ctr

New York, New York, United States

Site Status

Univ Hosps of Cleveland

Cleveland, Ohio, United States

Site Status

Roger Williams Med Ctr

Providence, Rhode Island, United States

Site Status

Milwaukee County Med Complex

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

Other Identifiers

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92-FT-57

Identifier Type: -

Identifier Source: secondary_id

240A

Identifier Type: -

Identifier Source: org_study_id