Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

Inclusion Criteria

Patient must have the following:

• AIDS as defined by CDC criteria.

• Retinitis as diagnosed by the study ophthalmologist.

• Performance status 0, 1, or 2.

• Ability to give informed consent and suitability of intravenous access for scheduled blood tests.

• Patient may have Kaposi's sarcoma or basal skin cancer.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Active acute infection requiring treatment.

• Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.

• Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Patients with the following are excluded:

• Active acute infection requiring treatment.

• Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.

• Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Prior Medication:

Excluded:

• Granulocyte macrophage colony-stimulating factor (GM-CSF).

• Colony stimulating factor.

• Interleukin 3.

• Excluded within 7 days of study entry:

• Zidovudine (AZT).

• Trimethoprim / sulfamethoxazole (TMP / SMX).

• Pyrimethamine.

• Excluded within 30 days of study entry:

• Biologic response modifiers.

• Cytotoxic agents.

• Investigational agents.

Prior Treatment:

Excluded:

• Radiation therapy.

Required within 1 week of study entry:

• One or more doses of ganciclovir.