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A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

NCT ID: NCT00002257

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.

Detailed Description

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Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.

Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have the following:

* Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria.
* CMV retinitis diagnosed within one month of study entry.
* Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.

Exclusion Criteria

Concurrent Medication:

The following are excluded:

* Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.

Patients with the following are excluded:

* Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.
* Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.
* Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).
* Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.
* History of hypersensitivity to acyclovir or ganciclovir.
* Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.

Prior Medication:

The following are excluded:

\- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

Davies Med Ctr / c/o HIV Institute

San Francisco, California, United States

Site Status

Dr David Busch

San Francisco, California, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Med Service

Miami, Florida, United States

Site Status

Miami Veterans Administration Med Ctr

Miami, Florida, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Site Status

New York Univ Med Ctr

New York, New York, United States

Site Status

Cornell Univ Med College

New York, New York, United States

Site Status

Buckley Braffman Stern Med Associates

Philadelphia, Pennsylvania, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Saint Paul's Hosp

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ICM 1653

Identifier Type: -

Identifier Source: secondary_id

059B

Identifier Type: -

Identifier Source: org_study_id