A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

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.