We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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: Primary Purpose: 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:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00001999     History of Changes
Other Study ID Numbers: 079A
219-90
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: April 1993

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:
HIV Infections
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Ganciclovir
Ganciclovir triphosphate
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors