Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Collecte de données
Infections transmises par le sang+22
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir. Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine. Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion. Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine. Lesions are covered by a nonabsorbent dressing. Medication is applied every 8 hours.
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.25 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: Included: * All medications deemed essential for best patient care, including zidovudine (AZT), Pneumocystis carinii pneumonia (PCP) prophylaxis, and acute or maintenance therapies for other opportunistic infections. Patients must have the following: * HIV infection or diagnosis of AIDS. * Mucocutaneous Herpes simplex virus infection. * Ability to give informed consent. Allowed: * Patients may be co-enrolled in other ACTG studies except for those in which treatments are expected to generate neutropenia. Subjects aged 13 - 17 may be enrolled with appropriate consent from parent or guardian. Exclusion Criteria Concurrent Medication: Excluded: * Acyclovir, ganciclovir, foscarnet, vidarabine or other investigational drugs with potential anti-Herpes simplex virus activity. Patients with the following are excluded: * Previous hypersensitivity reaction to trifluridine, polymyxin B or bacitracin. Prior Medication: Excluded: * Immunomodulators, lymphocyte replacement therapy or biologic response modifiers within 14 days 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
University of Colorado Hospital CRS
Aurora, United StatesCook County Hosp. CORE Ctr.
Chicago, United StatesNorthwestern University CRS
Chicago, United States