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

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.

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Key information

Conditions

Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Amino Acid Metabolism, Inborn Errors Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytomegalovirus Infections DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Genetic Diseases, Inborn Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases RNA Virus Infections Retinal Diseases Retinitis Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Globulin, Immune

Drug

Ganciclovir

Drug

Sponsors and collaborators

Lead sponsor

American National Red Cross

Other

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed