Search / Trial NCT00001061

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Aids Related Opportunistic Infections Ganciclovir Foscarnet Acquired Immunodeficiency Syndrome Antibodies, Monoclonal Cytomegalovirus Retinitis

ClinConnect Summary

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.

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 eve...

Gender

ALL

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.)

Trial Officials

Pollard RB

Study Chair

Borucki M

Study Chair

Gnann J

Study Chair

Hirsch MS

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

San Jose, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

Rochester, New York, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Honolulu, Hawaii, United States

Stanford, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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