Immune Activity Against CVM Retinitis

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

Keywords

ClinConnect Summary

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.