Terminé

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

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Ce qui est testé

Ganciclovir

Médicament
Qui peut participer

Cytomegalovirus Retinitis

+ HIV Infections
À partir de 13 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients. A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter. A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter. Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles (16 weeks). If CMV retinitis fails to arrest after initial induction, IV ganciclovir is administered for an additional 2 weeks.

Titre officielA Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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.
Détails du design
25 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 13 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
Cytomegalovirus Retinitis
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * Erythropoietin, G-CSF, or GM-CSF. * Antiretrovirals. Patients must have: * HIV infection. * Evaluable CMV retinitis with photographable lesions. * Life expectancy of at least 6 months. * No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression. * Corneal, lens, or vitreous opacification precluding funduscopic exam. * Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion. * Inability to obtain temporary IV access. * Requirement for permanent catheters for IV ganciclovir administration. * Uncontrolled diarrhea or nausea preventing ingestion of medicine. * Known hypersensitivity to IV or oral ganciclovir. Concurrent Medication: Excluded: * Immunomodulators. * Biologic response modifiers. * Interferon. * Related investigational agents. * CMV prophylaxis. * Systemic acyclovir. * Any nephrotoxic agent. * Any concomitant therapy that would prohibit use of ganciclovir. Prior Medication: Excluded: * Prior treatment for CMV retinitis. * More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks 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 6 sites
Suspendu
UCLA CARE Center CRSLos Angeles, United StatesVoir le site
Suspendu
Rush Univ. Med. Ctr. ACTG CRSChicago, United States
Suspendu
Johns Hopkins Adult AIDS CRSBaltimore, United States
Suspendu
Cornell University A2201New York, United States

Terminé6 Centres d'Étude