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首页> 美国政府科技报告 >Studies of the Ocular Complications of AIDS (SOCA) in Collaboration with the AIDS Clinical Trials Group (ACTG) Protocol 350 Ganciclovir Cidofovir CMV Retinitis Trial (GCCRT) Protocol, Version 6.1 (dated 06 Auguest 1999).
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Studies of the Ocular Complications of AIDS (SOCA) in Collaboration with the AIDS Clinical Trials Group (ACTG) Protocol 350 Ganciclovir Cidofovir CMV Retinitis Trial (GCCRT) Protocol, Version 6.1 (dated 06 Auguest 1999).

机译：研究艾滋病眼部并发症（sOCa）与艾滋病临床试验组（aCTG）协议350更昔洛韦西多福韦CmV视网膜炎试验（GCCRT）议定书，版本6.1（日期为1999年8月6日）。

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摘要

This document is the study protocol for the Ganciclovir Cidofovir CMV Retinitis Trial (GCCRT). The 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 regimen 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 regimens included intravenous ganciclovir, intravenous foscarnet, intermittent intravenous cidofivir, and intravenous ganciclovir induction followed by oral ganciclovir maintenance. Combination regimens were permitted for patients with relapsed retinitis. Treatment was administered according to standardized protocols. The outcome measure included mortality, retinitis progression, and loss of visual function (acuity and field).

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