An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

Hoffmann-La Roche

Overview

To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Cytomegalovirus Retinitis HIV Infections

Interventions

GanciclovirDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * AIDS. * Stable CMV retinitis. * Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days. * No permanent central IV catheter at present. * Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis. * Consent of guardian if less than legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Require continuation of concomitant medications precluded by this protocol. Concurrent Medication: Excluded: * Intravitreal anti-CMV treatment. * Any other concomitant medications precluded by the protocol. Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir or ganciclovir.

Locations (1)

Roche Global Development - Palo Alto

Palo Alto, California, United States

Data from ClinicalTrials.gov

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