A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT) - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000836 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Official Title ^ICMJE	A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Sevirumab
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000836
Responsible Party
Study ID Numbers ^ICMJE	ACTG 294
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	August 1998
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP