A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
Cidofovir
Infections transmises par le sang+20
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.
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.30 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: Antiretroviral therapy with AZT, ddI, ddC, or d4T. Oral trimethoprim/sulfamethoxazole. Dapsone. Atovaquone. Fluconazole. Rifabutin. Clarithromycin. Patients must have: HIV seropositivity. Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous). Measurable lesions. 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: Active medical problems sufficient to hinder study compliance or assessment of treatment effect. Concurrent Medication: Excluded: Acyclovir. Immunomodulators (such as corticosteroids or interferons). Lymphocyte replacement therapy. Biologic response modifiers. Ganciclovir. Foscarnet. Vidarabine. Topical trifluridine. Other investigational drugs (except d4T). Amphotericin. Intravenous therapy for PCP. Chemotherapeutic agents. Prior Medication: Excluded within 14 days prior to study entry: Immunomodulators (such as corticosteroids or interferons). Lymphocyte replacement therapy. Biologic response modifiers. Ganciclovir. Foscarnet. Vidarabine. Topical trifluridine. Other investigational drugs with potential anti-HSV activity. Amphotericin. Intravenous therapy for PCP. Excluded within 4 weeks prior to study entry: Chemotherapeutic agents. Required: At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous). Substance abuse.
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 9 sites
Los Angeles County - USC Med Ctr
Los Angeles, United StatesOuvrir Los Angeles County - USC Med Ctr dans Google MapsUCSF - San Francisco Gen Hosp
San Francisco, United StatesMount Zion Med Ctr / UCSF
San Francisco, United StatesRush Presbyterian - Saint Luke's Med Ctr
Chicago, United States