Studies of the Ocular Complications of AIDS (SOCA) in Collaboration with the Database Documentation for Ganciclovir Implant Pus Oral Ganciclovir Versus Parenteral Cidofovir for the Treament of Cytomegalovirus Tetinitis in Patients with Acquired Immunodef

摘要

The Ganciclovir Cidofovir CMV Retinitis Trial (GCCRT) was a Phase IV, randomized, multicenter trial conducted by the Studies of the Ocular Complications of AIDS (SOCA) in collaboration with the ACTG-350. The study was designed to compare the safety and efficacy of two treatment approaches for both newly diagnosed and relapsed CMV retinitis in people with AIDS. The two treatment approaches were: (1) the ganciclovir intraocular implant plus oral ganciclovir and (2) systemic treatment with any of several available treatment regimens for CMV retinitis. Patients randomized to the implant group had the implant surgically inserted at baseline and every 6 to 8 months thereafter in eyes with CMV (given that the patients had ongoing immune deficiency) and oral ganciclovir was taken at a dose of 1 gm three times daily. For patients randomized to systemic therapy only, permissible regimes included intravenous ganciclovir, intravenous foscamet, intermittent intravenous cidofovir, and intravenous ganciclovir induction followed by oral ganciclovir maintenance. Combination regimes were permitted for patients with relapsed retinitis. Treatment was administered according to standardized protocols. The outcome measures included mortality, retinitis progression, and loss of visual function (acuity and field).