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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000836 |
To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis.
Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.
Condition | Intervention | Phase |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Sevirumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT) |
Estimated Enrollment: | 300 |
Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.
Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication: Required:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Drug or alcohol abuse sufficient to hinder study compliance.
United States, California | |
UCSF - San Francisco Gen Hosp | |
San Francisco, California, United States, 94143 | |
UCSD - Shiley Eye Ctr / SOCA | |
La Jolla, California, United States, 920930946 | |
UCLA - Jules Stein Eye Institute / SOCA | |
Los Angeles, California, United States, 900957003 | |
United States, Illinois | |
Northwestern Univ / SOCA | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins Hosp / SOCA | |
Baltimore, Maryland, United States, 212879217 | |
United States, New York | |
New York Univ Med Ctr / SOCA | |
New York, New York, United States, 10016 |
Study ID Numbers: | ACTG 294 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000836 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Antibodies, Monoclonal Cytomegalovirus Retinitis |
Opportunistic Infections Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections Antibodies, Monoclonal Cytomegalovirus retinitis |
Virus Diseases Antibodies HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases Immunoglobulins |
RNA Virus Infections Slow Virus Diseases Immunologic Factors Eye Infections, Viral Immune System Diseases |
Physiological Effects of Drugs Lentivirus Infections Infection Pharmacologic Actions |