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.
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.
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
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
Other retinal disease that could obscure the diagnosis of CMV retinitis, such as ocular
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
Need for medications with anti-CMV effect.
Participation in conflicting clinical trial.
Progression of CMV retinitis between screening and baseline examinations.