Clinical trial NCT00002144: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Simplex
HIV Infections
Keywords: Herpes Simplex
Foscarnet
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: 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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: CARE Ctr / UCLA Med Ctr
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Miami
country: United States
facility: South Miami Hosp
state: Florida
city: Chicago
country: United States
facility: Dr Thomas Klein
state: Illinois
city: New York
country: United States
facility: Bellevue Hosp Ctr
state: New York
city: Cleveland
country: United States
facility: Univ Hosps of Cleveland
state: Ohio
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Milwaukee
country: United States
facility: Milwaukee County Med Complex
state: Wisconsin
Study officials:
name: Hardy WD
role: STUDY_CHAIR
References:
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