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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00002135

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.