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

Inclusion Criteria

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.