Abstract

This is an open-label, single-site, phase-II pilot study investigating the safety and virologic activity of AZT, 3TC, and Viracept in 12 antiretroviral-naove subjects with at least 10,000 HIV-1 RNA copies/ml plasma. After screening, all subjects will receive the following treatment regimen: AZT (Zidovudine) at 200 mg TID; 3TC (Lamivudine) at 150 mg BID; and Viracept (Nelfinavir) at 750 mg TID. In addition, the study will assess the feasibility of viral knockout with this potent therapeutic regimen. If study subjects become both culture and plasma RNA negative, gastrointestinal biopsy, lymph node (tonsillar) biopsy, lumbar puncture and genital secretion sampling will be used to assess the significance of the viral response. The study will also characterize the immunologic effects of suppression of viral load by lymphocyte phenotype studies, including markers for memory, activation, and cell cycling.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000102-35
Application #
6277112
Study Section
Project Start
1997-12-01
Project End
1999-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
35
Fiscal Year
1998
Total Cost
Indirect Cost

  Institution

Name
Rockefeller University
Department
Type
DUNS #
071037113
City
New York
State
NY
Country
United States
Zip Code
10065

  Publications

Bagdade, John D; Jilma, Bernd; Hudgins, Lisa C et al. (2018) LpA-II:B:C:D:E: a new immunochemically-defined acute phase lipoprotein in humans. Lipids Health Dis 17:127
Butelman, Eduardo Roque; Bacciardi, Silvia; Maremmani, Angelo Giovanni Icro et al. (2017) Can a rapid measure of self-exposure to drugs of abuse provide dimensional information on depression comorbidity? Am J Addict 26:632-639
Ansar, Muhammad; Raza, Syed Irfan; Lee, Kwanghyuk et al. (2015) A homozygous missense variant in type I keratin KRT25 causes autosomal recessive woolly hair. J Med Genet 52:676-80
Rosenbaum, Michael; Leibel, Rudolph L (2014) 20 years of leptin: role of leptin in energy homeostasis in humans. J Endocrinol 223:T83-96
Ohmatsu, Hanako; Humme, Daniel; Gulati, Nicholas et al. (2014) IL32 is progressively expressed in mycosis fungoides independent of helper T-cell 2 and helper T-cell 9 polarization. Cancer Immunol Res 2:890-900
Alemán, José O; Eusebi, Leonardo H; Ricciardiello, Luigi et al. (2014) Mechanisms of obesity-induced gastrointestinal neoplasia. Gastroenterology 146:357-373
Barbuto, Scott; Idoyaga, Juliana; Vila-Perelló, Miquel et al. (2013) Induction of innate and adaptive immunity by delivery of poly dA:dT to dendritic cells. Nat Chem Biol 9:250-6
Guo, Xiuyang; Dhodapkar, Kavita M (2012) Central and overlapping role of Cathepsin B and inflammasome adaptor ASC in antigen presenting function of human dendritic cells. Hum Immunol 73:871-8
Dustin, Lynn B; Charles, Edgar D (2012) Primary, post-primary and non-specific immunoglobulin M responses in HCV infection. Antivir Ther 17:1449-52
Pendyala, Swaroop; Walker, Jeanne M; Holt, Peter R (2012) A high-fat diet is associated with endotoxemia that originates from the gut. Gastroenterology 142:1100-1101.e2

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