A Phase II, Double-Masked, Randomized, Placebo-Controlled Evaluation of Standard Therapy vs. Standard Therapy Combined With Human Monoclonal Anti-Cytomegalovirus Antibody (MSL 109) in the Therapy of AIDS Patients With Cytomegalovirus (CMV) Retinitis
Collecte de données
Infections à cytomégalovirus+8
+ Infections par virus ADN
+ Maladies oculaires
Étude thérapeutique
Résumé
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients. Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days, then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression. Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance. They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks. Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs. AS PER AMENDMENT 11/29/96: Enrollment onto the current study has been discontinued. To study the enhancement of humoral immunity, a high-dose cohort has been added. Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before. Randomization is weighted 2:1 in favor of high-dose MSL 109. Interim analyses will be performed to provide for early discontinuation, as indicated. Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached.
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.167 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: * G-CSF and GM-CSF. * Antiretroviral therapy. Patients must have: * HIV infection. * First episode of CMV retinitis. * No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible. * No active AIDS-defining opportunistic infection or malignancy that requires nephrotoxic or myelosuppressive therapy. * Life expectancy of at least 6 months. * Consent of parent or guardian if less than 18 years of age. NOTE: * This protocol is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted). * Corneal, lens, or vitreous opacification that precludes funduscopic exam. * Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.) * Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression. * Known hypersensitivity to the study drugs. PER AMENDMENT 4/25/96: * Presence of CMV retinal lesions that are only in areas of the retina which cannot be photographed. Concurrent Medication: Excluded: * Immunomodulators, biologic response modifiers, interferon, or investigational agents that may influence course of CMV infection. * Systemic acyclovir or any nephrotoxic agent, specifically aminoglycosides, amphotericin B, and parenteral pentamidines. * Any concomitant therapy that would preclude use of cidofovir, foscarnet or ganciclovir. Prior Medication: Excluded: PER AMENDMENT 4/25/96: * Use of IV ganciclovir, foscarnet or cidofovir within 6 months prior to study enrollment. (Was written - Ganciclovir or foscarnet for non-CMV herpes infections within 6 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 20 sites
USC CRS
Los Angeles, United StatesSanta Clara Valley Med. Ctr.
San Jose, United StatesStanford CRS
Stanford, United States