drugset / Trial / NCT00089466
Safety and Activity of the Oral HIV Entry Inhibitor AMD11070 in HIV Infected Patients
Phase 1/2
Completed
6 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and anti-HIV activity of eight different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected patients.
Timeline
- Start
- 2004-11
- Primary completion
- 2006-06
- Completion
- 2009-01
Publications
- Background De Clercq E. Emerging anti-HIV drugs. Expert Opin Emerg Drugs. 2005 May;10(2):241-73. doi: 10.1517/14728214.10.2.241.
- Background Moore JP, Kitchen SG, Pugach P, Zack JA. The CCR5 and CXCR4 coreceptors--central to understanding the transmission and pathogenesis of human immunodeficiency virus type 1 infection. AIDS Res Hum Retroviruses. 2004 Jan;20(1):111-26. doi: 10.1089/088922204322749567.
- Background Reeves JD, Piefer AJ. Emerging drug targets for antiretroviral therapy. Drugs. 2005;65(13):1747-66. doi: 10.2165/00003495-200565130-00002.
- Background Ruibal-Ares BH, Belmonte L, Bare PC, Parodi CM, Massud I, de Bracco MM. HIV-1 infection and chemokine receptor modulation. Curr HIV Res. 2004 Jan;2(1):39-50. doi: 10.2174/1570162043484997.
- Background Shaheen F, Collman RG. Co-receptor antagonists as HIV-1 entry inhibitors. Curr Opin Infect Dis. 2004 Feb;17(1):7-16. doi: 10.1097/00001432-200402000-00003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mavorixafor | Small molecule | 200 mg | Oral |
| Subject | Mavorixafor | Small molecule | 400 mg | Oral |
| Subject | Mavorixafor | Small molecule | 600 mg | Oral |
| Subject | Mavorixafor | Small molecule | 800 mg | Oral |
| Subject | Mavorixafor | Small molecule | 1000 mg | Oral |
| Subject | Mavorixafor | Small molecule | 1500 mg | Oral |
| Subject | Mavorixafor | Small molecule | 2000 mg | Oral |