UAB Leads National Study to Test New HIV Drug

A study under way at the University of Alabama at Birmingham (UAB) aims to determine the safety and efficacy of the first drug of a new class of HIV drugs designed to prevent the virus from entering healthy cells. The national, multi-center study is led by Dr. Michael Saag, professor of medicine and director of UAB’s Center for AIDS Research.

April 14, 2005

BIRMINGHAM, AL — A study under way at the University of Alabama at Birmingham (UAB) aims to determine the safety and efficacy of the first drug of a new class of HIV drugs designed to prevent the virus from entering healthy cells. The national, multi-center study is led by Dr. Michael Saag, professor of medicine and director of UAB’s Center for AIDS Research.

The drug candidate, called AMD11070, was discovered and is being developed by AnorMed, a Canadian biopharmaceutical company. AnorMed and the National Institute of Allergy and Infectious Diseases (NIAID) are funding the study, which is being conducted by the U.S. Adult AIDS Clinical Trails Group, an arm of NIAID.

“Despite impressive advances in the treatment of HIV/AIDS, there is a need for new drugs to treat patients who have developed drug resistance to current therapies,” Saag said. “This new drug is one of the more promising ones to make it into clinical trials.”

HIV enters cells by binding to one of two receptors — CXCR4 or CCR5 — on the cell’s surface. “Up to 40 percent of patients are infected with a type of HIV that enters cells by way of the CXCR4 receptor,” Saag said. “This drug prevents the virus from entering cells by blocking this receptor.”

The three-month trial will enroll 48 patients nationally. “Here at UAB, we will recruit six to eight patients,” Saag said. “This phase of testing is designed to evaluate whether the drug is effective in reducing the amount of virus in the bloodstream and to further test the drug’s safety.”

Following an initial screening, eligible adult patients are admitted to participating site’s inpatient, NIH-sponsored General Clinical Research Center for 10 days for monitoring during treatment. Following treatment, patients return to the clinic four times over a period of 90 days for follow-up visits.

Researchers hope to present preliminary findings of the study this fall. “This is very exciting research,” Saag said. “We are pleased to be part of it.”

More information, including a list of participating sites, study investigators and contact information is available on the Web at www.clinicaltrials.gov. In Alabama, interested participants may contact Karen G. Savage, UAB nurse research manager, at (205) 975-7925 or by e-mail at kgsavage@uab.edu.