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| Sponsor: | Sandoz Inc. |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002016 |
Purpose
To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Sevirumab |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison |
| Official Title: | A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
Prior Treatment:
Excluded within 2 weeks of study entry:
Contacts and Locations| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
More Information
| Study ID Numbers: | 071B, Study No B103 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002016 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis Ganciclovir Cytomegalovirus |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antibodies, Monoclonal |
|
Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Physiological Effects of Drugs Retinitis Infection Antibodies, Monoclonal Pathologic Processes Syndrome Cytomegalovirus Infections Retroviridae Infections Retinal Diseases RNA Virus Infections Disease |
Immune System Diseases Eye Infections, Viral Eye Diseases Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Antibodies HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |