Completed

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

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What is being tested

Foscarnet sodium

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorAstra USA
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002144
Principal SponsorAstra USA
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin Diseases, ViralSkin and Connective Tissue DiseasesAcquired Immunodeficiency SyndromeHerpes SimplexHIV Infections

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

CARE Ctr / UCLA Med Ctr

Los Angeles, United StatesOpen CARE Ctr / UCLA Med Ctr in Google Maps

George Washington Univ Med Ctr

Washington D.C., United States

South Miami Hosp

Miami, United States

Dr Thomas Klein

Chicago, United States
Completed8 Study Centers