Miami, Florida 33143

  • HIV Infections

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

240A


NCT ID:

NCT00002144


Secondary ID:

92-FT-57


Study Acronym:


Brief Title:

The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acy


Official Title:

The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Primary


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:


Overall Contact Information

Official Name:Hardy WD
Study Chair

Study Dates

Verification Date:March 1996
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Foscarnet sodium

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astra USA

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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