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

NCT00001999 | Completed

• 2 other identifiers: 079A219-90
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Keywords

Retinitis; Gamma-Globulins; Ganciclovir; Drug Therapy, Combination; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Immunization, Passive

Interventions

Globulin, Immune DRUG

Ganciclovir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• American National Red Cross: lead

Study Sites (1)

Georgetown Univ Med Ctr

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

Location

MeSH Terms

Conditions

Cytomegalovirus Retinitis; HIV Infections; Retinitis; Multiple Acyl Coenzyme A Dehydrogenase Deficiency; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome

Interventions

Immunoglobulins; Ganciclovir

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinal Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1993-04

Locations

US (1)