Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001999
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1993

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00001999 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
  • Drug: Globulin, Immune
  • Drug: Ganciclovir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001999
079A, 219-90
Not Provided
Not Provided
American National Red Cross
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
April 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP