A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Safety Study
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Valganciclovir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	200
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Concurrent Medication: Allowed with caution: Acyclovir. Famciclovir. Valaciclovir. Imipenem-cilastatin. 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. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms of conditions are excluded: Active extraocular CMV disease. Severe uncontrolled diarrhea or evidence of malabsorption. Concurrent Medication: Excluded: Foscarnet. Cidofovir. CMV hyperimmune globulin. Probenecid. 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). Required: A minimum of 4 weeks treatment with ganciclovir, foscarnet, or cidofovir. Approval required for prior use of investigational anti-CMV agents.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002222
Responsible Party
Study ID Numbers ^ICMJE	268B
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP