HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Cidofovir
+ Probenecid
Infections transmises par le sang+22
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.
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.100 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: Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. Fluconazole. Ketoconazole. Itraconazole. Rifabutin. Filgrastim (G-CSF). Antiretroviral agents. Patients must have: AIDS by CDC criteria. CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field. Prior Medication: Allowed: Prophylaxis with anti-CMV agents. Exclusion Criteria Concurrent Medication: Excluded: Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity. Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine. Patients with the following prior conditions are excluded: History of renal disease or renal dialysis. History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. History of clinically significant probenecid allergy. Prior Medication: Excluded: Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity. Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine. Drug or alcohol abuse sufficient to hinder compliance with study.
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 7 sites
UCSD - Shiley Eye Ctr / SOCA
La Jolla, United StatesOuvrir UCSD - Shiley Eye Ctr / SOCA dans Google MapsUCLA - Jules Stein Eye Institute / SOCA
Los Angeles, United StatesUCSF - San Francisco Gen Hosp
San Francisco, United StatesNorthwestern Univ / SOCA
Chicago, United States