This protocol describes a phase 1/2 safety and pharmacokinetic study of escalating doses of AMD-3100 administered by continuous intravenous infusion for 10 days in stable HIV-infected patients with viral load >5000 copies/ml. To be eligible, patients are required to be on no antiretroviral therapy or to be taking a stable regimen of antiretroviral drugs for >4 weeks prior to inpatient admission for study drug administration. The ojectives of the study are to assess the safety, pharmacokinetics, and antiviral activity of AMD-3100 administered for 10 consecutive days by continuous intravenous infusion. Each cohort of 4 patients will receive AMD-3100 at successively higher doses, if the previous dose was well tolerated by at least 3 of the 4 patients in the cohort. Patients will be hospitalized for the duration of the study and continue taking the same antiretroviral drugs (or none) unless the development of drug related adverse events warrants drug discontinuation. AMD-3100 is a member of a new class of """"""""fusion inhibitors"""""""", which acts to block entry of HIV into CD4+ cells by interaction with the human CXCR4 co-receptor. Objectives: 1) to determine the safety, pharmacokinetics, and antiviral activity of escalating doses of AMD-3100 administered by continuous intravenous infusion for 10 days in HIV-infected patients on stable or no antiretroviral therapy. 2) to correlate the antiviral activity of AMD-3100 with the co-receptor assay results at baseline and at the end of treatment.""""""""

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-38
Application #
6420766
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
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
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Osman, Ahmed Fageer; Thomas, Biju; Singh, Nakul et al. (2017) Impact of Infant-Polysomnography Studies on Discharge Management and Outcomes: A 5 Year Experience from a Tertiary Care Unit. J Neonatal Biol 6:
Tita, Alan T N; Lai, Yinglei; Landon, Mark B et al. (2017) Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol 34:1464-1469
Grams, Morgan E; Yang, Wei; Rebholz, Casey M et al. (2017) Risks of Adverse Events in Advanced CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis 70:337-346

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