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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	American National Red Cross
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00001999

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.

Condition	Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Globulin, Immune Drug: Ganciclovir

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium Immunoglobulins Globulin, Immune

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001999

Locations

United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007

Sponsors and Collaborators

American National Red Cross

More Information

No publications provided

Study ID Numbers:	079A, 219-90
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001999 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
Gamma-Globulins
Ganciclovir
Drug Therapy, Combination

Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Immunization, Passive

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immunologic Factors
Physiological Effects of Drugs
Retinitis
Infection
Therapeutic Uses
Cytomegalovirus Infections
Retroviridae Infections
Retinal Diseases
Immunoglobulins
RNA Virus Infections
Immune System Diseases

Eye Infections, Viral
Eye Diseases
Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Eye Infections
Ganciclovir
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Antibodies
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 05, 2009