Expired Study
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Washington, District of Columbia 20007


Purpose:

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.


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


Study is Available At:


Original ID:

079A


NCT ID:

NCT00001999


Secondary ID:

219-90


Study Acronym:


Brief Title:

A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:April 1993
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Globulin, Immune
Intervention Type:Drug
Name:Ganciclovir

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:American National Red Cross

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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