This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Step 3/Cohort J: AMD11070/Ritonavir (RTV) Interaction This is a phase I, open-label, multiple dose, and sequential design drug interaction study that will consist of one cohort of healthy volunteers. Volunteers will be dosed initially with 200 mg AMD11070 alone on Day 1. On Days 1-3 blood samples will be taken for analysis of AMD11070 concentration (AMD11070 alone phase). Volunteers will not receive any drug on Day 2 to allow clearance of nearly all (estimated to be > 93%) of the first AMD11070 dose. On Day 3, volunteers will begin taking RTV (100 mg bid) through Day 18 (for a total of 16 consecutive days, 32 total doses). A single 200-mg dose of AMD11070 will also be given simultaneously with the morning RTV dose on Day 3. On Days 3-5, frequent blood samples will be taken for PK analysis of AMD11070 and RTV concentrations (acute RTV phase). There will be blood collection to measure RTV levels within 6 hours after dosing on Day 10 or 11. On Day 17, volunteers will receive another 200-mg dose of AMD11070 simultaneously with their morning RTV dose. The evening RTV dose on Day 18 will be the last dose. On Days 17-19, blood samples will again be taken for analysis of AMD11070 and RTV concentrations (steady-state RTV phase). Safety of AMD11070 alone and during co-administration with RTV will be assessed throughout the study period. Coadministration of low-dose ritonavir (RTV) will increase the AMD11070 PK exposure. AMD11070 will not affect the RTV PK exposure.
| Robert Braši?, James; Mari, Zoltan; Lerner, Alicja et al. (2018) Remission of Gilles de la Tourette Syndrome after Heat-Induced Dehydration. Int J Phys Med Rehabil 6: |
| Altman, Matthew C; Whalen, Elizabeth; Togias, Alkis et al. (2018) Allergen-induced activation of natural killer cells represents an early-life immune response in the development of allergic asthma. J Allergy Clin Immunol 142:1856-1866 |
| AIDS-defining Cancer Project Working Group of IeDEA, COHERE in EuroCoord (2018) Non-Hodgkin lymphoma risk in adults living with HIV across five continents. AIDS 32:2777-2786 |
| Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671 |
| Elion, Richard A; Althoff, Keri N; Zhang, Jinbing et al. (2018) Recent Abacavir Use Increases Risk of Type 1 and Type 2 Myocardial Infarctions Among Adults With HIV. J Acquir Immune Defic Syndr 78:62-72 |
| Al-Sofiani, Mohammed E; Yanek, Lisa R; Faraday, Nauder et al. (2018) Diabetes and Platelet Response to Low-Dose Aspirin. J Clin Endocrinol Metab 103:4599-4608 |
| Grover, Surbhi; Desir, Fidel; Jing, Yuezhou et al. (2018) Reduced Cancer Survival Among Adults With HIV and AIDS-Defining Illnesses Despite No Difference in Cancer Stage at Diagnosis. J Acquir Immune Defic Syndr 79:421-429 |
| Grams, Morgan E; Sang, Yingying; Ballew, Shoshana H et al. (2018) Predicting timing of clinical outcomes in patients with chronic kidney disease and severely decreased glomerular filtration rate. Kidney Int 93:1442-1451 |
| Yanik, Elizabeth L; Hernández-Ramírez, Raúl U; Qin, Li et al. (2018) Brief Report: Cutaneous Melanoma Risk Among People With HIV in the United States and Canada. J Acquir Immune Defic Syndr 78:499-504 |
| Aboud, Katherine S; Barquero, Laura A; Cutting, Laurie E (2018) Prefrontal mediation of the reading network predicts intervention response in dyslexia. Cortex 101:96-106 |
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