A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus
The purpose of this study is to determine the safety and activity of AMD11070 in HIV-infected patients carrying X4-tropic virus.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Dose-finding Safety and Activity Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus.|
- safety and antiviral activity of AMD11070 administered in HIV-infected patients who harbor-X4-tropic virus. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- the proportion of patients per cohort who have a ≥1 log10 rlu reduction in X4-tropic virus and to describe changes from baseline to Day 10 in log10 rlu corresponding to X4-tropic virus. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- the relationship between standard pharmacokinetic (PK) measures, viral response, and a shift in T-cell receptor tropism. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- the relationship of coreceptor tropism phenotype to CD4+ count, viral load, and drug resistance in the screening patient population. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- the virologic activity of AMD11070 at day 10 of study treatment by analyzing the proportion of patients with Plasma HIV-1 RNA levels <400 and <50 copies/ml and the proportion with a >1 log10 decline in plasma HIV from baseline. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- changes in CD4+ cell counts and percentages on and off AMD11070. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- change from baseline in CD34+ cells [ Time Frame: 10 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
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.
|United States, Florida|
|Orlando, Florida, United States, 32803|
|London, United Kingdom, SW10 9TH|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|