The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Foscarnet sodium
Infections transmises par le sang+20
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.12 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 13 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 8 sites
George Washington Univ Med Ctr
Washington D.C., United StatesSouth Miami Hosp
Miami, United StatesDr Thomas Klein
Chicago, United States