A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
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.
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||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
| Estimated Enrollment:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Allowed with caution:
- Myelosuppressive agents.
Patients must have:
- 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.
Patients with any of the following symptoms of conditions are excluded:
- Active extraocular CMV disease.
- Severe uncontrolled diarrhea or evidence of malabsorption.
- CMV hyperimmune globulin.
Patients with the following prior conditions are excluded:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002222
|Cornell AIDS Clinical Trials Unit
|New York, New York, United States, 10021 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Drug Administration Schedule
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections
Eye Infections, Viral