search
Back to results

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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Globulin, Immune
Ganciclovir
Sponsored by
American National Red Cross
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Gamma-Globulins, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunization, Passive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
American National Red Cross
search

1. Study Identification

Unique Protocol Identification Number
NCT00001999
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 Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
American National Red Cross

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Gamma-Globulins, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunization, Passive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Globulin, Immune
Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs