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) Data Collection Forms (as of 24 September 1999).

摘要

This document contains the study data collection forms 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 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 regimens included intravenous ganciclovir, intravenous foscarnet, intermittent intravenous cidofovir, 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 measures included mortality, retinitis progression, and loss of visual function (acuity and field). Annotated data collection forms (i.e., corresponding variable name written on form for each item/question) can be obtained along with datasets for published papers from the SOCA Coordinating Center upon request.