A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
Cytomegalovirus Retinitis, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Gamma-Globulins, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunization, Passive
Eligibility Criteria
Inclusion Criteria Patients must have the following: First episode of sight-threatening CMV retinitis. At least one pending culture for CMV from the blood or urine prior to entry. Life expectancy > 6 months. Karnofsky performance = or > 60. Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Known selective IGA deficiency or antibodies against IgA. History of previous episodes of sight-threatening CMV retinitis. Patients with the following are excluded: Previous episode of sight-threatening CMV retinitis. Concomitant treatment with other investigational agents except ddI or ddC. Life expectancy < 6 months. Continued alcohol or drug abuse. Known selective IgA deficiency and known to have antibodies against IgA. Karnofsky performance <60. Other investigational agents except ddI or ddC. ddI ddC
Sites / Locations
- Georgetown Univ Med Ctr