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

Launched by SCHERING-PLOUGH · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.