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

Roche

Status: Completed

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002135

GANS2224

037C

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.