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Home > "A" Clinical Trials Conditions > A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)  A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Primary CMV treatment. Patients must have: - AIDS. - Active CMV retinitis. - At least one photographable lesion of one-quarter or more optic disc area in size. - Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109. - Visual acuity in at least one eye of 3 or more letters on Early Treatment Diabetic Retinopathy Study ( ETDRS ) chart at 1 meter distance ( Snellen equivalent 5/200 ). Note: - Exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Retinal detachment not scheduled for surgical repair. - Media opacity that precludes visualization of the fundus. - Active medical problems sufficient to hinder study compliance. Concurrent Medication: Excluded: - IVIG. - CMV immune globulin ( CMVIG ). - Interferon alpha. - Interferon gamma. - Interleukin-2 ( IL-2 ). Drug or alcohol abuse sufficient to hinder study compliance.
Total Enrollment: 300
Location and Contact Information:
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, 920930946
United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611
United States
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, 212879217
United States
New York Univ Med Ctr / SOCA
New York City, New York, 10016
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94143
United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, 900957003
United States
Additional Information:
Study ID Numbers: ACTG 294;
Study Start Date:
Record last reviewed: August 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000836
Other Hiv Infections Studies:
1. Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication
2. The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients
3. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
4. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
5. A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment
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A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
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