Search / Trial NCT00001611

Immune Activity Against CVM Retinitis

Launched by NATIONAL EYE INSTITUTE (NEI) · Nov 3, 1999

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Aids Eye Treatment Opportunistic Infection Immunology Retinitis

Description

This is a clinical trial to determine whether elevated CD4 counts resulting from medications against human immunodeficiency virus (HIV) are effective in controlling cytomegalovirus (CMV) retinitis. Patients with non-progressive retinal disease consistent with inactive CMV retinitis in a location that is not immediately sight threatening, who are currently receiving systemic maintenance therapy with ganciclovir, foscarnet, or cidofovir, and who have a total CD4 cell count greater than 150 cells per microliter will have their anti-CMV therapy discontinued. Patients will then be closely follow...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Diagnosis of AIDS as defined by the Centers for Disease Control.
  • Inactive, non-sight-threatening CMV retinitis. Non sight-threatening CMV retinitis is defined as CMV retinitis not within 1000 microns from the optic disc or 1000 microns from the fovea. Exception: patients with CMV retinitis within 1000 microns of the fovea or disc in only one eye, if visual acuity in that eye is worse than 20/400 without the use of eccentric fixation, and visual acuity in the other eye is 20/400 or better.
  • CD4 T cell count greater than 150 cells per microliter.
  • Patients must be able understand the nature of the study, agree to the provision, and understand and sign the informed consent form.
  • Women and men age 18 or older are eligible for enrollment.
  • Platelets greater than 25,000/microliter.
  • Hemoglobin greater than 8.5 gms.
  • Total neutrophil count greater than 750/mm(3).
  • Karnofsky performance score greater than or equal to 60.
  • Receiving systemic anti-CMV therapy.
  • Receiving anti-HIV therapy. If the patient is receiving IL-2, at least one month from last infusion must elapse prior to assessment for eligibility.
  • EXCLUSION CRITERIA:
  • Intraocular sustained release ganciclovir implant in the eye for less than 9 months, or other organ involvement from CMV infection requiring use of systemic ganciclovir or foscarnet.
  • CMV retinitis should not involve the retina solely anterior to the equator, or within 1000 microns from the optic disc, or within 1000 microns from the fovea. Exception: patients with lesions that have involved the fovea or disc and caused visual acuity worse than 20/400 without the use of eccentric fixation, may be included.
  • Opacification of the cornea, lens, or vitreous in either eye that precludes examination of the fundus.
  • Other retinal disease that could obscure the diagnosis of CMV retinitis, such as ocular toxoplasmosis.
  • Significant psychiatric or emotional disorders that would impair patient understanding or participation in the trial.
  • Life expectancy less than three months.
  • Active CMV disease requiring systemic anti-CMV therapy.
  • CMV retinitis first diagnosised with CD4 T-cell count greater than 150 cells per microliter.
  • Need for medications with anti-CMV effect.
  • Participation in conflicting clinical trial.
  • Progression of CMV retinitis between screening and baseline examinations.

Attachments

readout_NCT00001611_2024-06-13.pdf

4.5 MB

NCT00001611_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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