A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
Ganciclovir
Blood-Borne Infections+30
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Davies Med Ctr / c/o HIV Institute
San Francisco, United StatesDr David Busch
San Francisco, United StatesGeorgetown Univ Med Ctr
Washington D.C., United States