Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Efficacy of Elevated CD4 Cell Counts on CMV Retinitis
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 serious side effects. AIDS patients are prone to this infection because their
immune system produces a lower number of CD4+T lymphocytes, the type of blood cells that
fight viral infections.
Some new HIV medications strengthen the immune system. This study will investigate the
possibility that CMV patients on these HIV medications can develop immune systems strong
enough to fight CMV without CMV medication. The study will enroll a maximum of 15 adult
HIV/AIDS patients who have a CD4+T cell count over 150 cells/microliter and who have
inactive CMV retinitis that is not immediately sight threatening. It is expected to last
approximately 2 years.
Each prospective participant will have a physical examination and complete eye examination,
including retina photographs, with the eye examination and retina photographs repeated 2
weeks later. If there is no evidence of active CMV retinitis, the participant will be
enrolled in the study, and CMV medication will be stopped. The participant will have
physical and eye examinations every 2 weeks for the first 3 months of the study, and every 3
weeks for the next 3 months. After 6 months, the frequency of the examinations will be 2-8
weeks, depending on the participant's CD4 count. After one year, a participant with a CD4
count remaining over 150 cells/microliter may return to the care of a local ophthalmologist
with HIV/CMV experience, revisiting the clinical center every 6 months. The participant's
CMV medication will be restarted when CMV retinitis becomes active, which will terminate
participation in the study.
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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