Clinical Trials Directory

Trials / Completed

CompletedNCT00002016

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
—
Sponsor
Sandoz · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGSevirumab

Timeline

First posted
2001-08-31
Last updated
2005-06-24

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00002016. Inclusion in this directory is not an endorsement.