Status:
COMPLETED
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Facet Biotech
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief 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 eval...
Detailed Description
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 demonstrate...
Eligibility 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.)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1998
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00001061
End Date
March 1 1998
Last Update
November 1 2021
Active Locations (20)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
USC CRS
Los Angeles, California, United States, 900331079
3
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 951282699
4
Stanford CRS
Stanford, California, United States, 943055107