Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
NCT ID: NCT00001061
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
1998-03-31
Brief Summary
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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.
Detailed Description
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Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days, then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression. Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance. They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks. Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs. AS PER AMENDMENT 11/29/96: Enrollment onto the current study has been discontinued. To study the enhancement of humoral immunity, a high-dose cohort has been added. Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before. Randomization is weighted 2:1 in favor of high-dose MSL 109. Interim analyses will be performed to provide for early discontinuation, as indicated. Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Sevirumab
Foscarnet sodium
Ganciclovir
Eligibility Criteria
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Inclusion Criteria
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
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.)
13 Years
ALL
No
Sponsors
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Facet Biotech
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Pollard RB
Role: STUDY_CHAIR
Borucki M
Role: STUDY_CHAIR
Gnann J
Role: STUDY_CHAIR
Hirsch MS
Role: STUDY_CHAIR
Locations
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Alabama Therapeutics CRS
Birmingham, Alabama, United States
USC CRS
Los Angeles, California, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
Stanford CRS
Stanford, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Queens Med. Ctr.
Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
Countries
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References
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Borucki M, Spritzler J, Gnann J, Hirsch M, Nokta M, Aweeka F, Pollard R. A phase II double masked, 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 newly diagnosed cytomegalovirus (CMV) retinitis in ACTG 266. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:154 (abstract no 460)
CMV retinitis study aborted. GMHC Treat Issues. 1996 Sep;10(9):8.
Borucki MJ, Spritzler J, Asmuth DM, Gnann J, Hirsch MS, Nokta M, Aweeka F, Nadler PI, Sattler F, Alston B, Nevin TT, Owens S, Waterman K, Hubbard L, Caliendo A, Pollard RB; AACTG 266 Team. A phase II, double-masked, randomized, placebo-controlled evaluation of a human monoclonal anti-Cytomegalovirus antibody (MSL-109) in combination with standard therapy versus standard therapy alone in the treatment of AIDS patients with Cytomegalovirus retinitis. Antiviral Res. 2004 Nov;64(2):103-11. doi: 10.1016/j.antiviral.2004.06.012.
Other Identifiers
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11242
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 266
Identifier Type: -
Identifier Source: org_study_id