NCT00361101

A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus

Multicenter, Dose-finding Safety and Activity Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and activity of AMD11070 in HIV-infected patients carrying X4-tropic virus.

Detailed description

AMD11070 is a new chemical entity that inhibits HIV-1 entry by binding specifically and reversibly to CXCR4, a coreceptor required by T-tropic virus for membrane fusion and entry into cells. The purpose of this study is to evaluate the safety and relative antiretroviral activity of AMD11070 in HIV-infected individuals who have demonstrated X4 -tropic virus in their plasma. With the ongoing development of other fusion and entry inhibitors and the need for alternative treatment options in patients (especially those with multidrug resistant virus), the demonstration of activity and safety of AMD11070 represents a potentially important advance in antiretroviral therapeutics. This will be the first study that determines the therapeutic potential of anti-CXCR4 compounds in HIV-infected patients. Note: Study was previously suspended due to non-clinical reports of hepatotoxicity and histologic findings. Study has been completed.

Conditions

• HIV Infections
• X4 Tropic Virus

Interventions

Type	Name	Description
DRUG	AMD11070	200 mg PO BID (by mouth two times per day) for 10 days.

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-08-01
• Completion: 2010-04-01
• First posted: 2006-08-07
• Last updated: 2014-02-11

Locations

2 sites across 2 countries: United States, United Kingdom