Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4 + Lymphocyte Counts in Patients with Uncontrolled HIV Infection

Jeffrey M. Jacobson, Michael M. Lederman, John Spritzler, Hernan Valdez, Pablo Tebas, Gail Skowron, Rui Wang, J. Brooks Jackson, Lawrence Fox, Alan Landay, Mark J. Gilbert, Dorothy O'Neil, Lynne Bancroft, Lena Al-Harthi, Mark A. Jacobson, Thomas C. Merigan, Marshall J. Glesby

Research output: Contribution to journalArticle

Abstract

Background. Studies have reported that plasma human immunodeficiency virus type 1 (HIV-1) RNA levels and CD4+ lymphocyte counts in HIV-infected patients improved after treatment with granulocyte-macrophage colony-stimulating factor (GM-CSF). Methods. In AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 μg of GM-CSF administered subcutaneously 3 times/week, followed by open-label treatment for an additional 32 weeks. Patients had stable baseline plasma HIV-1 RNA levels of ≥ 1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study. Results. After 16 weeks, the GM-CSF group tended to have greater, though clinically insignificant, increases in plasma HIV-1 RNA levels, compared with the placebo group (median change, +0.048 vs. -0.103 log copies/mL; P = .036, in a post hoc analysis). There were trends toward progressive modest increases in CD4+ lymphocyte counts with GM-CSF treatment at 16 weeks (median change, +14 vs. -6 cells/mm3; P = .06) and beyond. Conclusions. GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.

Original languageEnglish (US)
Pages (from-to)1804-1814
Number of pages11
JournalJournal of Infectious Diseases
Volume188
Issue number12
DOIs
StatePublished - Dec 15 2003

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Virus Diseases
Granulocyte-Macrophage Colony-Stimulating Factor
CD4 Lymphocyte Count
HIV-1
HIV
RNA
Placebos
Clinical Protocols
Virus Replication
Antiviral Agents
Acquired Immunodeficiency Syndrome
Therapeutics
Randomized Controlled Trials
Clinical Trials

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

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Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4 + Lymphocyte Counts in Patients with Uncontrolled HIV Infection. / Jacobson, Jeffrey M.; Lederman, Michael M.; Spritzler, John; Valdez, Hernan; Tebas, Pablo; Skowron, Gail; Wang, Rui; Jackson, J. Brooks; Fox, Lawrence; Landay, Alan; Gilbert, Mark J.; O'Neil, Dorothy; Bancroft, Lynne; Al-Harthi, Lena; Jacobson, Mark A.; Merigan, Thomas C.; Glesby, Marshall J.

In: Journal of Infectious Diseases, Vol. 188, No. 12, 15.12.2003, p. 1804-1814.

Research output: Contribution to journalArticle

Jacobson, JM, Lederman, MM, Spritzler, J, Valdez, H, Tebas, P, Skowron, G, Wang, R, Jackson, JB, Fox, L, Landay, A, Gilbert, MJ, O'Neil, D, Bancroft, L, Al-Harthi, L, Jacobson, MA, Merigan, TC & Glesby, MJ 2003, 'Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4 + Lymphocyte Counts in Patients with Uncontrolled HIV Infection', Journal of Infectious Diseases, vol. 188, no. 12, pp. 1804-1814. https://doi.org/10.1086/379899
Jacobson, Jeffrey M. ; Lederman, Michael M. ; Spritzler, John ; Valdez, Hernan ; Tebas, Pablo ; Skowron, Gail ; Wang, Rui ; Jackson, J. Brooks ; Fox, Lawrence ; Landay, Alan ; Gilbert, Mark J. ; O'Neil, Dorothy ; Bancroft, Lynne ; Al-Harthi, Lena ; Jacobson, Mark A. ; Merigan, Thomas C. ; Glesby, Marshall J. / Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4 + Lymphocyte Counts in Patients with Uncontrolled HIV Infection. In: Journal of Infectious Diseases. 2003 ; Vol. 188, No. 12. pp. 1804-1814.
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abstract = "Background. Studies have reported that plasma human immunodeficiency virus type 1 (HIV-1) RNA levels and CD4+ lymphocyte counts in HIV-infected patients improved after treatment with granulocyte-macrophage colony-stimulating factor (GM-CSF). Methods. In AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 μg of GM-CSF administered subcutaneously 3 times/week, followed by open-label treatment for an additional 32 weeks. Patients had stable baseline plasma HIV-1 RNA levels of ≥ 1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study. Results. After 16 weeks, the GM-CSF group tended to have greater, though clinically insignificant, increases in plasma HIV-1 RNA levels, compared with the placebo group (median change, +0.048 vs. -0.103 log copies/mL; P = .036, in a post hoc analysis). There were trends toward progressive modest increases in CD4+ lymphocyte counts with GM-CSF treatment at 16 weeks (median change, +14 vs. -6 cells/mm3; P = .06) and beyond. Conclusions. GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.",
author = "Jacobson, {Jeffrey M.} and Lederman, {Michael M.} and John Spritzler and Hernan Valdez and Pablo Tebas and Gail Skowron and Rui Wang and Jackson, {J. Brooks} and Lawrence Fox and Alan Landay and Gilbert, {Mark J.} and Dorothy O'Neil and Lynne Bancroft and Lena Al-Harthi and Jacobson, {Mark A.} and Merigan, {Thomas C.} and Glesby, {Marshall J.}",
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T1 - Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4 + Lymphocyte Counts in Patients with Uncontrolled HIV Infection

AU - Jacobson, Jeffrey M.

AU - Lederman, Michael M.

AU - Spritzler, John

AU - Valdez, Hernan

AU - Tebas, Pablo

AU - Skowron, Gail

AU - Wang, Rui

AU - Jackson, J. Brooks

AU - Fox, Lawrence

AU - Landay, Alan

AU - Gilbert, Mark J.

AU - O'Neil, Dorothy

AU - Bancroft, Lynne

AU - Al-Harthi, Lena

AU - Jacobson, Mark A.

AU - Merigan, Thomas C.

AU - Glesby, Marshall J.

PY - 2003/12/15

Y1 - 2003/12/15

N2 - Background. Studies have reported that plasma human immunodeficiency virus type 1 (HIV-1) RNA levels and CD4+ lymphocyte counts in HIV-infected patients improved after treatment with granulocyte-macrophage colony-stimulating factor (GM-CSF). Methods. In AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 μg of GM-CSF administered subcutaneously 3 times/week, followed by open-label treatment for an additional 32 weeks. Patients had stable baseline plasma HIV-1 RNA levels of ≥ 1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study. Results. After 16 weeks, the GM-CSF group tended to have greater, though clinically insignificant, increases in plasma HIV-1 RNA levels, compared with the placebo group (median change, +0.048 vs. -0.103 log copies/mL; P = .036, in a post hoc analysis). There were trends toward progressive modest increases in CD4+ lymphocyte counts with GM-CSF treatment at 16 weeks (median change, +14 vs. -6 cells/mm3; P = .06) and beyond. Conclusions. GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.

AB - Background. Studies have reported that plasma human immunodeficiency virus type 1 (HIV-1) RNA levels and CD4+ lymphocyte counts in HIV-infected patients improved after treatment with granulocyte-macrophage colony-stimulating factor (GM-CSF). Methods. In AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 μg of GM-CSF administered subcutaneously 3 times/week, followed by open-label treatment for an additional 32 weeks. Patients had stable baseline plasma HIV-1 RNA levels of ≥ 1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study. Results. After 16 weeks, the GM-CSF group tended to have greater, though clinically insignificant, increases in plasma HIV-1 RNA levels, compared with the placebo group (median change, +0.048 vs. -0.103 log copies/mL; P = .036, in a post hoc analysis). There were trends toward progressive modest increases in CD4+ lymphocyte counts with GM-CSF treatment at 16 weeks (median change, +14 vs. -6 cells/mm3; P = .06) and beyond. Conclusions. GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.

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