Abstract

This randomized, controlled, open-label multi-center trial is designed to compare the intracellular delay in onset of suppression of HIV-1 viral replication within the first 72 hours of initiation of antiretroviral therapy using indinavir, or nevirapine, or combination zidovudine(ZDV)/3TC. All subjects receive four-drug combination therapy from 72 hours forward. Additionally, the trial evaluates whether (GM-CSF and IL-12) cytokines which stimulate the proliferation and activation of monocytes and macrophages, when added to antiretroviral therapy, can hasten the clearance of HIV from these cells. The study also measures several aspects of T cell recovery. Twenty-four HIV-1 infected subjects will be enrolled in total; 8 will be enrolled at the Rockefeller GCRC. All will be naove to prior antiretroviral therapy, and will have been HIV-1 infected for at least 6 months. The study duration is 72 weeks. If preliminary results suggest a significant increase in the clearance rate of HIV-1 and the sponsor (ACTG), the FDA and IRB approve, the study may be amended to extend immune modulation.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000102-38
Application #
6567242
Study Section
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2002
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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