A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
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To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
Condition or disease
Cytomegalovirus RetinitisHIV Infections
Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.
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Ages Eligible for Study:
13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Topical and ophthalmic nucleoside analogues.
Patients must have:
No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
Currently stable retinitis.
Foscarnet prior to the 4 weeks of intravenous induction therapy.
Patients with the following symptoms or conditions are excluded:
Persistent or clinically significant diarrhea, nausea, or abdominal pain.
Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.
Acyclovir sodium (Zovirax) by any route other than topical.
Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)