The safety and efficacy of granulocyte-macrophage colony-stimulating factor (sargramostim) added to indinavir- or ritonavir-based antiretroviral therapy: A randomized double-blind, placebo-controlled trial

Journal of Infectious Diseases

Volumn 180, Issue 4, 1999, Pages 1064-1071

  Skowron, Gail ^a   Stein, Daniel ^d,f   Drusano, George ^d   Melbourne, Kathleen ^b,c   Bilello, John ^d   Mikolich, Dennis ^a   Rana, Khurram ^c   Agosti, Jan M ^e   Mongillo, Anne ^e   Whitmore, James ^e   Gilbert, Mark J ^e  

^a ROGER WILLIAMS MEDICAL CENTER   (United States)

^b Department of Pharmacy   (United States)

^c UNIVERSITY OF RHODE ISLAND   (United States)

^d ALBANY MEDICAL COLLEGE   (United States)

^e AMGEN INC   (United States)

^f GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CD4 ANTIGEN; INDINAVIR; INTERLEUKIN 10; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; RITONAVIR; TUMOR NECROSIS FACTOR RECEPTOR; VIRUS RNA;

ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MALE; NAUSEA; NEUTROPHILIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; T LYMPHOCYTE SUBPOPULATION; VIRUS LOAD;

ADULT; ANTI-HIV AGENTS; ANTIGENS, CD; BIOLOGICAL MARKERS; CONFIDENCE INTERVALS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GRANULOCYTE MACROPHAGE COLONY-STIMULATING FACTORS, RECOMBINANT; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; INDINAVIR; INTERLEUKIN-10; MALE; MIDDLE AGED; PLACEBOS; RECEPTORS, TUMOR NECROSIS FACTOR; RECEPTORS, TUMOR NECROSIS FACTOR, TYPE I; RECEPTORS, TUMOR NECROSIS FACTOR, TYPE II; RECOMBINANT PROTEINS; RITONAVIR; RNA, VIRAL; VIRAL LOAD;

EID: 0033396014     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/314981     Document Type: Article

References (45)

1. Metcalf D, Begley CG, Johnson GR, et al. Biologic properties in vitro of a recombinant human granulocyte-macrophage colony-stimulating factor. Blood 1986; 67:37-45.
2. Smith PD, Lamerson CK, Banks SM, et al. Granulocyte-macrophage colony-stimulating factor augments human monocyte fungicidal activity for Candida albicans. J Infect Dis 1990; 161:999-1005.
3. Richardson MD, Brownlie CED, Shankland GS. Enhanced phagocytosis and intracellular killing of Candida albicans by sargramostim-activated human neutrophils. J Med Vet Mycol 1992; 30:433-41.
4. Wang M, Friedman H, Djeu JY. Enhancement of human monocyte function against Candida albicans by the colony-stimulating factors (CSF): IL-3, granulocyte-macrophage-CSF, and macrophage-CSF. J Immunol 1989; 143:671-7.
5. Grabstein KH, Urdal D, Tushinski RJ, et al. Induction of macrophage tumoricidal activity by granulocyte-macrophage colony-stimulating factor. Science 1986; 232:506-8.
6. Coleman DL, Chodakewitz JA, Bartiss AH, Mellors JW. Granulocyte-macrophage colony stimulating factor enhances selective effector functions of tissue-derived macrophages. Blood 1988; 72:573-8.
7. Fischer HG, Fiosch S, Reske K, et al. Granulocyte-macrophage colony stimulating factor activates macrophages derived from bone marrow cultures to synthesize MHC class II molecules and to augmented antigen presentation function. J Immunol 1988; 141:3882-8.
8. Weisbart RH, Golde DW, Clark SC, Wong GG, Gasson JC. Human granulocyte-macrophage colony-stimulating factor is a neutrophil activator. Nature 1985; 314:361-3.
9. Fletcher MP, Gasson JC. Enhancement of neutrophil function by granulocyte-macrophage colony-stimulating factor involves recruitment of a less responsive subpopulation. Blood 1988; 71:652-8.
10. Morrissey PH, Bressler L, Park LS, Alpert A, Gillis S. Granulocyte-macrophage colony-stimulating factor augments the primary antibody response by enhancing the function of antigen-presenting cells. J Immunol 1987; 139:1113-9.
11. Lopez AF, Nicola NA, Burgess AW, et al. Activation of granulocyte cytotoxic function by purified mouse colony-stimulating factors. J Immunol 1983; 131:2983-8.
12. Hammer SM, Gillis JM. Synergistic activity of granulocyte-macrophage colony stimulating factor and 3′-azido-3′-doxythynmidine against human immunodeficiency virus in vitro. Antimicrob Agents Chemother 1987; 31:1046-50.
13. Hammer SM, Gillis JM, Pinkston P, Rose RM. Effect of zidovudine and granulocyte-macrophage colony-stimulating factor on human immuno-deficiency virus replication in alveolar macrophages. Blood 1990; 75:1215-9.
14. Perno CF, Cooney DA, Gao WY, et al. Effects of bone marrow stimulatory cytokines on human immunodeficiency virus replication and the antiviral activity of dideoxynucleosides in cultures of monocyte/macrophages. Blood 1992; 80:995-1003.
15. Pluda JM, Mitsuya H, Yarchoan R. Hematologic effects of AIDS therapies. Hematol Oncol Clin North Am 1991; 5:229-48.
16. Pluda JM, Yarchoan R, Smith PD, et al. Subcutaneous recombinant granulocyte-macrophage colony-stimulating factor used as a single agent and in an alternating regimen with azidothymidine in leukopenic patients with severe human immunodeficiency virus infection. Blood 1990; 76:463-72.
17. Scadden DT, Bering HA, Levine JD, et al. Granulocyte-macrophage colony stimulating factor mitigates the neutropenia of combined interferon alpha and zidovudine treatment of acquired immunodeficiency syndrome associated Kaposi's sarcoma. J Clin Oncol 1991; 9:802-8.
18. Levine JD, Allan JD, Tessitore JH, et al. Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS related complex. Blood 1991; 78:3148-54.
19. Barbaro G, Di Lorenzo G, Gisorio B, Soldini M, Barbarini G. Effect of recombinant human granulocyte-macrophage colony-stimulating factor on HIV-related leukopenia: a randomized, controlled clinical study. AIDS 1997; 11:1453-61.
20. Perno CF, Gessani S, Aquaro S, et al. Activity of sargramostim and M-CSF upon replication of HIV and other DNA- and RNA-viruses in primary macrophages [abstract 463]. In: 3rd Conference on Retroviruses and Opportunistic Infections: program and abstracts (28 January 1 February 1996, Washington, DC). Alexandria, VA: Infectious Diseases Society of America. 1996.
21. Crows SM, Lopex A. GM-CSF and its effect on replication of HIV-1 cells of macrophage lineage. J Leukoc Biol 1997; 62:41-8.
22. Matsuda S, Akagawa K, Honda M, Yokota Y, Tukebe Y, Takemori T. Suppression of HIV replication in human monocyte derived macrophages induced by granulocyte/macrophage colony-stimulating factor. AIDS Res Hum Retroviruses 1995; 11:1031-8.
23. Di Marzio P, Mariani R, Tse J, Thomas EK, Landau NR. GM-CSF or CD40L suppresses chemokine receptor expression on HIV-1 entry in human monocytes and macrophages [abstract 37]. In: 5th Conference on Retroviruses and Opportunistic Infections: program and abstracts (February 1998; Alexandria, VA). Alexandria: Infectious Diseases Society of America, 1998.
24. Di Marzio P, Tse J, Landau NR, et al. Chemokine receptor regulation and HIV type 1 tropism in monocyte-macrophages. AIDS Retroviruses 1998; 14:129-38.
25. Mitsuyasu RT. Clinical uses of hematopoietic growth hormones in HIV-related disease. In: Volberding P, Jacobson MA, eds. AIDS clinical review. New York: Marcel Dekker, 1994; 189-212.
26. Folks TM, Justement J, Kinter A, Dinarello CA, Fauci AS. Cytokine induced expression of HIV-1 in a chronically infected promonocyte cell line. Science 1987; 238:800-2.
27. Osborn L, Kunkel S, Nabel GJ. Tumor necrosis factor alpha and interleukin 1 stimulate the human immunodeficiency virus enhancer by activation of the nuclear factor κ B. Proc Natl Acad Sci USA 1989; 86:2336-40.
28. Koyangi Y, O'Brien WA, Zhao JQ, Golde DW, Gasson JC, Chen IS. Cytokines alter production of HIV-1 from primary mononuclear phagocytes. Science 1988; 241:1673-5.
29. Scadden D, Pickus O, Hammer S, et al. Lack of in vivo effects of granulocyte-macrophage colony-stimulating factor on human immunodeficiency virus type 1. AIDS Hum Retroviruses 1996; 12:1151-9.
30. Davison FD, Kaczmarski RS, Pozniak A, Mufti GJ, Sutherland S. Quantification of HIV by PCR in monocytes and lymphocytes in patients receiving antiretroviral treatment and low dose recombinant human granulocyte macrophage colony stimulating factor. J Clin Pathol 1994; 47:855-7.
31. Bernstein ZP, Brooks S, Hayes FA, Gould M, Jacob S, Tomasi TB. A pilot study in the use of GM-CSF in human immunodeficiency virus (HIV) infected individuals [abstract]. Blood 1997; 90:133a.
32. Stricker RB, Goldberg B. Increase in lymphocyte subsets following treatment of HIV-associated neutropenia with granulocyte colony-stimulating factor. Clin Immunol Immunopathol 1996; 79:194-6.
33. Kaplan CD, Kahn JO, Crowe SM, et al. Clinical and virologic effects of recombinant human granulocyte macrophage colony stimulating factor (sargramostim) in patients receiving chemotherapy for human immuno-deficiency virus associated non-Hodgkin's lymphoma. Results of a randomized trial. J Clin Oncol 1991; 9:929-40.
34. Scadden DT, Bering HA, Levine JD, et al. GM-CSF as an alternative to dose modification of the combination zidovudine and interferon-alpha in the treatment of AIDS-associated Kaposi's sarcoma. Am J Clin Oncol 1991; 14(Suppl 1):40-4S.
35. Rana KZ, Okereke CS, Melbourne KM, et al. Effect of GM-CSF on the pharmacokinetics of indinavir in HIV-infected patients. In: Program and abstracts of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (San Diego, September 1998), Washington, DC: American Society for Microbiology, 1998.
36. Palumbo PE, Raskino C, Fiscus S, et al. Predictive value of quantitative plasma HIV RNA and CD4′ lymphocyte count in HIV-infected infants and children. JAMA 1998; 279:756-61.
37. Stein DS, Lyles RH, Graham NMH, et al. Predicting clinical progression or death in subjects with early state HIV infection: a comparative analysis of quantification of HIV, RNA, soluble TNFR receptors, neopterin, and 2-microglobulin. J Infect Dis 1997; 176:1161-7.
38. Yerly S, Perneger TV, Hirschel B, et al. A critical assessment of the prognostic value of HIV-1 RNA levels and CD4′ cell counts in HIV-infected patients. Arch Intern Med 1998; 158:247-52.
39. Cameroni B, Chiozzi MH, Kraveiki S, et al. Prolongation of life and prevention of AIDS in advanced HIV immunodeficiency with ritonavir [abstract LB6a]. In: 3rd Conference on Retroviruses and Opportunistic Infections: program and abstracts (28 January- 1 February 1996, Washington, DC). Alexandria, VA: Infectious Diseases Society of America, 1996.
40. Hammer SM, Squires KE, Hughes MD, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. N Engl J Med 1997; 337:725-33.
41. Gulick RM, Mellors JW, Havlir D, et al. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med 1997; 337:734-9.
42. Pialoux G, Raffi F, Brunvezinet F, et al. Prospective randomized evaluation of three maintenance regimens for HIV infected adults receiving induction therapy with zidovudine (ZDV), lamivudine (3TC), and indinavir (1DV): the TRILEGE trial [abstract 1-88]. In: Program and abstracts of the 37th Interscience Conference on Antimicrobial Agents and chemotherapy (1997, Toronto). Washington, DC: American Society for Microbiology. 1997.
43. Gill MJ, Beall G, Beattie D, et al. Safety of saquinavir soft gelatin capsule (SQV-SGC) in combination with other antiretroviral agents: multicenter study NV15182: 24 week analysis [abstract 1-90]. In: Program and abstracts of the 37th Interscience Conference on Antimicrobial Agents and chemotherapy (1997, Toronto). Washington, DC: American Society for Microbiology, 1997.
44. Kovacs JA, Baselar M, Dewar RJ, et al. Increases in CD4 T lymphocytes with intermittent course of interleukin-2 in patients with human immunodeficiency virus infection. A preliminary study. N Engl J Med 1995; 332:567-75.
45. Kovacs JA, Vogel S, Albert JM, et al. Controlled trial of interleukin-2 infusions in patients infected with the human immunodeficiency virus, N Engl J Med 1996; 335:1350-6.