Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS

• Status: Completed
• Trial end date: 1998-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers.

Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Facet Biotech
• Treatments: Foscarnet; Ganciclovir; Ganciclovir triphosphate; Phosphonoacetic Acid

Criteria

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.)