This is a Phase I safety and tolerance study of a novel new anti-HIV therapy. The objective of this trial is to determine the safety and pharmacokinetics of escalating doses of AMD-3100 in healthy volunteers. AMD-3100 (AnorMED, Inc.) is a novel antiretroviral compound, a bicyclam, whose mechanism of action differs from that of currently licensed antiretroviral drugs. In in vitro studies, AMD-3100 inhibits HIV replication after virus adsorption to cells, but before the reverse transcription step (De Clercq et al. 1994). Further, these studies showed that AMD-3100 inhibits the entry of HIV virus, both HIV-1 and HIV-2, into CD4+ T-cells and other cells in which the CXCR-4 receptor is used for entry. It did not inhibit the binding of ligands for the CCR5 chemokine receptor. Virus that enters by the use of the CXCR-4 receptor is thought to be responsible for the progression of HIV infection and the immunopathogenesis, which leads to AIDS. This inhibition of entry extends to the capability of AMD-3100 to block fusion of HIV infected cells with other CD4+ cells. This ability of AMD-3100 may help prevent pathogenesis caused by such events in the lymph nodes as well as the periphery.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000052-40
Application #
6457890
Study Section
Special Emphasis Panel (ZRR1)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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