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:
American National Red Cross
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
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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| 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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00001999 History of Changes |
| Other Study ID Numbers: | 079A, 219-90 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Retinal Diseases Eye Diseases |
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Antibodies Immunoglobulins Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013