An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: November 1995
History of Changes
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.
Drug : Ganciclovir
Primary Purpose: Treatment
|Official Title:||An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- 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.
- Require continuation of concomitant medications precluded by this protocol.
- Intravitreal anti-CMV treatment.
- Any other concomitant medications precluded by the protocol.
Patients with the following symptoms or conditions are excluded:
History of hypersensitivity to acyclovir or ganciclovir.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002135
Locations Show More
|United States, California|
|Roche Global Development - Palo Alto|
|Palo Alto, California, United States, 94303|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002135 History of Changes|
|Other Study ID Numbers:||037C|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Retinitis
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.