A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis - 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 NCT00002134 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Official Title ^ICMJE	A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Brief Summary	To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Detailed Description	Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Ganciclovir
Study Arms / Comparison Groups
Publications *	Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4. No abstract available.
* 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	450
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Concurrent Medication: Allowed: Topical drugs and ophthalmics. Patients must have: AIDS. Unilateral CMV retinitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease. Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography. Acute retinal necrosis or any other intraocular condition that might preclude study completion. Ocular condition requiring immediate surgery. Unable to have long-term IV catheter placement. Concurrent Medication: Excluded: Vidarabine. Amantadine hydrochloride. Cytarabine. FIAC or FIAU. Idoxuridine. Ribavirin. Valacyclovir. Foscarnet. CMV hyperimmune globulin. Soluble CD4. Trichosanthin. Imipenem-cilastatin. Isoprinosine. Levamisole. Interferon. Other investigational drugs. Patients with the following prior conditions are excluded: History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated. History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded: Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment). Prior intravitreal ganciclovir implant. More than two prior induction dose courses of IV anti-CMV therapy (per amendment). Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
Gender	Both
Ages	13 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	NCT00002134
Responsible Party
Study ID Numbers ^ICMJE	037B, GANS2304
Study Sponsor ^ICMJE	Roche Global Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	July 1997
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP