Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, Gamma-Globulins, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunization, Passive
Brief summary
To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.
Interventions
DRUGGlobulin, Immune
DRUGGanciclovir
Sponsors
American National Red Cross
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed