Status:
COMPLETED
Efficacy of Elevated CD4 Counts on CMV Retinitis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Eligibility:
All Genders
Brief Summary
Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV all have seriou...
Detailed 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. Pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
End Date :
April 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00091884
Start Date
July 1 2004
End Date
April 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892