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Sponsored by: |
American National Red Cross |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00001999 |
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 |
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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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Patients with the following are excluded:
Other investigational agents except ddI or ddC.
ddI ddC
Study ID Numbers: | 079A, 219-90 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001999 |
Health Authority: | United States: Food and Drug Administration |
Retinitis Gamma-Globulins Ganciclovir Drug Therapy, Combination |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Immunization, Passive |
Sexually Transmitted Diseases, Viral Gamma-Globulins Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Cytomegalovirus retinitis Virus Diseases Antibodies HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases Immunoglobulins |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immunologic Factors Eye Infections, Viral Immune System Diseases |
Therapeutic Uses Physiological Effects of Drugs Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |