drugset / Trial / NCT00766597
Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents
Phase 1/2
Completed
9 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
NaSingle-groupOpen-labelTreatment
Summary
Complications with current HIV antiretroviral therapy have left many children and adolescents with limited therapeutic options due to drug resistance. The purpose of this study is to test the effectiveness and safety of Vicriviroc (VCV), an HIV entry inhibitor and CCR5 co-receptor antagonist.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-07
- Completion
- 2010-08
Publications
- Background Lorenzen T, Stoehr A, Walther I, Plettenberg A. CCR5 antagonists in the treatment of treatment-experienced patients infected with CCR5 tropic HIV-1. Eur J Med Res. 2007 Oct 15;12(9):419-25.
- Background Rusconi S, Scozzafava A, Mastrolorenzo A, Supuran CT. An update in the development of HIV entry inhibitors. Curr Top Med Chem. 2007;7(13):1273-89. doi: 10.2174/156802607781212239.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vicriviroc | Small molecule | 0.8 mg/kg | Oral |
| Subject | Vicriviroc | Small molecule | 1 mg/ml | Oral |
| Subject | Vicriviroc | Small molecule | 20 mg | Oral |
| Subject | Vicriviroc | Small molecule | 30 mg | Oral |