A Phase II, Double-Masked, Randomized, Placebo-Controlled Evaluation of Standard Therapy vs. Standard Therapy Combined With Human Monoclonal Anti-Cytomegalovirus Antibody (MSL 109) in the Therapy of AIDS Patients With Cytomegalovirus (CMV) Retinitis

Inclusion Criteria

Concurrent Medication:

Allowed:

• G-CSF and GM-CSF.
• Antiretroviral therapy.

Patients must have:

• HIV infection.
• First episode of CMV retinitis.
• No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible.
• No active AIDS-defining opportunistic infection or malignancy that requires nephrotoxic or myelosuppressive therapy.
• Life expectancy of at least 6 months.
• Consent of parent or guardian if less than 18 years of age.

NOTE:

• This protocol is approved for prisoner participation.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted).
• Corneal, lens, or vitreous opacification that precludes funduscopic exam.
• Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.)
• Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression.
• Known hypersensitivity to the study drugs.

PER AMENDMENT 4/25/96:

• Presence of CMV retinal lesions that are only in areas of the retina which cannot be photographed.

Concurrent Medication:

Excluded:

• Immunomodulators, biologic response modifiers, interferon, or investigational agents that may influence course of CMV infection.
• Systemic acyclovir or any nephrotoxic agent, specifically aminoglycosides, amphotericin B, and parenteral pentamidines.
• Any concomitant therapy that would preclude use of cidofovir, foscarnet or ganciclovir.

Prior Medication:

Excluded: PER AMENDMENT 4/25/96:

• Use of IV ganciclovir, foscarnet or cidofovir within 6 months prior to study enrollment. (Was written - Ganciclovir or foscarnet for non-CMV herpes infections within 6 months prior to study entry.)

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety