Clinical 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

This study has been completed.

Sponsored by: American National Red Cross
Information provided by: 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 Treatment or Intervention
Cytomegalovirus Retinitis
HIV Infections
 Drug: Globulin, Immune
 Drug: Ganciclovir

MedlinePlus related topics:  AIDS;   Cytomegalovirus Infections;   Eye Diseases;   Retinal Disorders;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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


Location Information


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

More Information

Study ID Numbers:  079A; 219-90
Record last reviewed:  April 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001999
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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