Abstract

This is a phase-II/III, randomized, two-armed comparison study to compare micronized atovaquone and azithromycin (AT/AZ) with trimethoprim-sulfamethoxazole (TMP/SMX) in preventing serious bacterial infections in HIV-infected children 3 months to 19 years of age. After stratifying for previous use of TMP/SMX and/or IVIG, subjects will be randomized to one of two arms, TMP/SMX (5 mg/kg/day) OR micronized atovaquone (30 mg/kg/day) plus azithromycin (5 mg/kg/day). Both arms will have matching placebos. Subjects will be evaluated for safety and tolerance of the study drugs. Cross-over to an alternative study-drug regimen will occur for either arm if a serious treatment-related toxicity is observed. Subjects will also be tested for equivalence of antibacterial agents by the monitoring for occurrence of serious bacterial infections or PCP breakthrough. When a serious bacterial infection endpoint (a second infection is identified) is reached, subjects will be crossed over to the alternative study-drug regimen. The first 30 subjects will have a pharmacokinetic profile performed to assist in insuring that the previously established blood concentrations of azithromycin and atovaquone are not significantly affected by the administration of the two drugs in combination.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000096-38
Application #
6115795
Study Section
Project Start
Project End
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

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

  Publications

Jun, Gyungah R; Chung, Jaeyoon; Mez, Jesse et al. (2017) Transethnic genome-wide scan identifies novel Alzheimer's disease loci. Alzheimers Dement 13:727-738
Homann, O R; Misura, K; Lamas, E et al. (2016) Whole-genome sequencing in multiplex families with psychoses reveals mutations in the SHANK2 and SMARCA1 genes segregating with illness. Mol Psychiatry 21:1690-1695
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
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
Ghani, Mahdi; Reitz, Christiane; Cheng, Rong et al. (2015) Association of Long Runs of Homozygosity With Alzheimer Disease Among African American Individuals. JAMA Neurol 72:1313-23
Beecham, Gary W; Dickson, Dennis W; Scott, William K et al. (2015) PARK10 is a major locus for sporadic neuropathologically confirmed Parkinson disease. Neurology 84:972-80

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