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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001999
• Other study ID #: 079A
• Secondary ID: 219-90
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Globulin, Immune

• Ganciclovir

Locations

Country	Name	City	State
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
American National Red Cross

Country where clinical trial is conducted

United States,