ACTG379: DISCONTINUATION OF THERAPY FOR CYTOMEGALOVIRUS RETINITIS

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This is a prospective study of the discontuation of maintenance therapy for CMV retinitis. Subjects in Groups 1 and 2 with treated and healed non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis. Healed retinitis will be defined as the lack of opacity at the border or the presence of dry hard opacity that is stable or decreasing after multiple visits as interpreted by an experienced ophthalmologist and confirmed by fundus photographs (27). Subjects must have received therapy with any anti-CMV regimen for at least 8 weeks prior to study entry. However, subjects that have received the ganciclovir intraocular implant <7 months prior to study entry are excluded from participation. Subjects must also have either CD4+ counts > 100 cells/mm3 or CD4+ counts between 50-100 cells/mm3 and a > or equal to (200 copies/ml using the Roche Amplicor RT PCR assay) while receiving potent antiretroviral therapy for at least 8 weeks prior to study entry. Subjects (n=25) who meet the eligibility criteria for this study, but who choose to continue to receive maintenance therapy, may also participate in this study. All subjects will be studied longitudinally to evaluate the relationship between reactivation and progression of CMV disease and changes in CMV, DNA, HIV-1 RNA, and CD4+ cell counts.