Abstract

The incidence and prevalence of HIV-1 infection in the worldwide pediatric population is rapidly increasing. The major mode of transmission is the vertical passage of HIV-1 from mother to infant. The majority of these infants will develop symptoms within the first two years of life. Many of the currently available antiretroviral therapies have a limited time span of utility due to toxicities or the emergence of resistance. The development of new drugs for use in the pediatric population is critical. Ritonavir is a competetive selective inhibitor of the HIV protease. It is currently used in adults with AIDS. This is a phase I/II, dose finding, open label study of HIV-infected infants and children, who will be statified by age into 2 dose cohorts. The subjects will be given ritonavir along with lamivudine(3TC) and zidovudine(ZDV). The primary objective is to assess the pharmacokinetics of ritonavir, alone and in combination with 3TC and ZDV and determine any potential age-related differences. Other objectives are to determine the suitable dose of ritonavir in combination with 3TC and ZDV. Antiretroviral activity and immunological effects will be studied. Plasma virus and lymphocyte kinetics will be modeled. The rapidity with which virus becomes resistant to ritonavir will be determined in vivo.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-39
Application #
6412374
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1975-10-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
New York University
Department
Type
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10016

  Publications

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Ridge, Perry G; Hoyt, Kaitlyn B; Boehme, Kevin et al. (2016) Assessment of the genetic variance of late-onset Alzheimer's disease. Neurobiol Aging 41:200.e13-200.e20
Hohman, Timothy J; Bush, William S; Jiang, Lan et al. (2016) Discovery of gene-gene interactions across multiple independent data sets of late onset Alzheimer disease from the Alzheimer Disease Genetics Consortium. Neurobiol Aging 38:141-150
Jun, G; Ibrahim-Verbaas, C A; Vronskaya, M et al. (2016) A novel Alzheimer disease locus located near the gene encoding tau protein. Mol Psychiatry 21:108-17
Ebbert, Mark T W; Boehme, Kevin L; Wadsworth, Mark E et al. (2016) Interaction between variants in CLU and MS4A4E modulates Alzheimer's disease risk. Alzheimers Dement 12:121-129
Hohman, Timothy J; Cooke-Bailey, Jessica N; Reitz, Christiane et al. (2016) Global and local ancestry in African-Americans: Implications for Alzheimer's disease risk. Alzheimers Dement 12:233-43
Mukherjee, Shubhabrata; Walter, Stefan; Kauwe, John S K et al. (2015) Genetically predicted body mass index and Alzheimer's disease-related phenotypes in three large samples: Mendelian randomization analyses. Alzheimers Dement 11:1439-1451
Østergaard, Søren D; Mukherjee, Shubhabrata; Sharp, Stephen J et al. (2015) Associations between Potentially Modifiable Risk Factors and Alzheimer Disease: A Mendelian Randomization Study. PLoS Med 12:e1001841; discussion e1001841
Li, Yi; Tsui, Wai; Rusinek, Henry et al. (2015) Cortical laminar binding of PET amyloid and tau tracers in Alzheimer disease. J Nucl Med 56:270-3

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