A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Cytomegalovirus Retinitis, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir. Didanosine (ddI) may be continued or initiated in any patient during the study. Topical acyclovir. Topical ophthalmics. Aerosolized pentamidine. Patients must have: AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV. Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea. Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex. Life expectancy of at least 4 months. Exclusion Criteria Co-existing Condition: Patients with ocular conditions requiring immediate surgical correction are excluded. Concurrent Medication: Excluded during first 4 weeks of ganciclovir treatment: Zidovudine (AZT). Excluded: Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines. Patients with the following are excluded: Immediately sight-threatening retinitis (= or < 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or < 3000 microns from the fovea). Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment. Demonstrated hypersensitivity to acyclovir. Prior Medication: Excluded: - Previous treatment with anti-cytomegalovirus therapy.
Sites / Locations
- Univ of California / San Diego Treatment Ctr
- Mount Zion Med Ctr
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Pacific Presbyterian
- Mills Hosp
- Stanford Univ School of Medicine
- George Washington Univ Med Ctr
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Indiana Univ Hosp
- Henry Ford Hosp
- Univ of Minnesota
- Kansas City Veterans Administration Med Ctr
- Washington Univ Med Ctr
- Univ of New Mexico Hlth Sciences Ctr / Dept of Med
- New York Univ Med Ctr / Dept of Environmental Med
- Cornell Univ Med Ctr
- Holmes Hosp / Univ of Cincinnati Med Ctr
- Univ TX Galveston Med Branch
- Plaza Med Ctr
- Infectious Diseases Association of Houston / Methodist Hosp
- Infectious Disease Physicians Inc