HIV Infection Clinical Trial
Official title:
Efficacy of Elevated CD4 Cell Counts on CMV Retinitis
This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral
infection of the eye-can safely be stopped in HIV-infected patients whose immune function
has improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir,
foscarnet, and cidofovir) can cause serious side effects, such as low blood counts and
kidney damage. Stopping these medications may, therefore, be beneficial.
Patients with HIV infection who develop CVM retinitis usually have very low levels of
infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of
blood. New anti-HIV medications have been able to raise CD4 levels and improve immune
function in many patients. This study will see if patients with CD4 levels above 150 cells
per microliter can fight CVM retinitis without additional anti-CVM drugs.
HIV-infected patients with CVM retinitis will have a physical examination and complete eye
examination. These tests will be repeated after 2 weeks. If there is no evidence that the
CMV infection has progressed, and if it is in a location that is not immediately
sight-threatening, anti-CMV medications will be stopped. Patients will be examined every 2
weeks for 3 months and then every 3 weeks for the next 3 months. Patients whose CD4 count
has remained above 100 after 6 months will continue to be followed every 4 weeks until the
CVM infection becomes active again. At that time, anti-CVM medicines will be re-started.
Patients will also have blood and urine samples taken to test for levels of HIV and CMV in
the blood and urine, and will be interviewed about their vision and how it affects daily
activities.
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 followed for progression of their CMV retinitis. The primary endpoint of the study will be progression of CMV retinitis. Secondary endpoints will include the occurrence of extraocular CMV disease, morbidity, mortality, virologic data, and HIV burden. ;
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