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A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS



A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS

For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 200

Location and Contact Information:

Cornell AIDS Clinical Trials Unit
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  268B; 
Study Start Date: 
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002222

Other Cytomegalovirus Retinitis Studies:
1. A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure

2. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

3. A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

4. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease

5. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Cannot Use Ganciclovir

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