A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1999
History of Changes
The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past. This study also examines the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis.
Drug : Valganciclovir
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Label Study of the Safety and Tolerability of Valganciclovir, an Oral Prodrug of Ganciclovir, for the Treatment of Cytomegalovirus Retinitis in Subjects With AIDS|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients receive valganciclovir twice a day for 21 days as induction therapy then daily as maintenance therapy. Patients are encouraged to remain on study for at least 3 months and will remain until common study closure.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Allowed with caution:
- Myelosuppressive agents.
- HIV infection with CMV retinitis.
- Minimum of 4 weeks prior treatment with ganciclovir, foscarnet, or cidofovir.
- Intraocular implant in either or both eyes, as long as CMV retinitis is active in one eye, upon approval by Roche.
- Active extraocular CMV disease.
- Severe uncontrolled diarrhea or evidence of malabsorption.
- CMV hyperimmune globulin.
- Ocular media opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment.
- Simultaneous participation in another study (unless approved by Roche).
- A minimum of 4 weeks treatment with ganciclovir, foscarnet, or cidofovir.
- Approval required for prior use of investigational anti-CMV agents.
Patients must have:
Patients with any of the following symptoms of conditions are excluded:
Patients with the following prior conditions are excluded:
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: NCT00002222
Locations Show More
|United States, New York|
|Cornell AIDS Clinical Trials Unit|
|New York, New York, United States, 10021|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002222 History of Changes|
|Other Study ID Numbers:||268B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Drug Administration Schedule
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.