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

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002135

Run by

Hoffmann-La Roche

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Roche Global Development - Palo Alto — Palo Alto, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.