A phase II, double-masked, randomized, placebo-controlled evaluation of a human monoclonal anti-Cytomegalovirus antibody (MSL-109) in combination with standard therapy versus standard therapy alone in the treatment of AIDS patients with Cytomegalovirus retinitis

Antiviral Research

Volumn 64, Issue 2, 2004, Pages 103-111

  Borucki, Michael J ^a   Spritzler, John ^b   Asmuth, David M ^c   Gnann, John ^d   Hirsch, Martin S ^e   Nokta, Mostafa ^f   Aweeka, Francesca ^g   Nadler, Paul I ^h   Sattler, Fred ⁱ   Alston, Beverly ^j   Nevin, Thomas T ^k   Owens, Susan ^l   Waterman, Karen ^m   Hubbard, Larry ⁿ   Caliendo, Angela ^o   Pollard, Richard B ^c  

^a UNIVERSITY OF TEXAS HEALTH CENTER   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL   (United States)

^f NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h PROTEIN DESIGN LABS INC   (United States)

ⁱ UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^j NATIONAL INSTITUTES OF HEALTH   (United States)

^k SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

^l FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^m UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

ⁿ UNIVERSITY OF WISCONSIN MADISON   (United States)

^o EMORY UNIVERSITY HOSPITAL   (United States)

more..

Author keywords

AIDS; Cytomegalovirus; Cytomegalovirus retinitis; Monoclonal antibody; MSL 109

Indexed keywords

ANTIVIRUS AGENT; CIDOFOVIR; FOSCARNET; GANCICLOVIR; PLACEBO; SEVIRUMAB;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADOLESCENT; ADULT; AGED; ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DISEASE COURSE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG MEGADOSE; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 2 CLINICAL TRIAL; PHOTOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETINITIS; SIDE EFFECT; STANDARDIZATION; SURVIVAL RATE; TOXICITY;

ADULT; AIDS-RELATED OPPORTUNISTIC INFECTIONS; ANTIBODIES, MONOCLONAL; ANTIVIRAL AGENTS; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS RETINITIS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FOSCARNET; GANCICLOVIR; HUMANS; MALE; TREATMENT OUTCOME; VIRAL ENVELOPE PROTEINS;

CUCUMBER MOSAIC VIRUS; CYTOMEGALOVIRUS;

EID: 7444237579     PISSN: 01663542     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.antiviral.2004.06.012     Document Type: Article

References (46)

1. Anon. Treatment of serious cytomegalovirus infections with 9-(1,3-dihydroxy-2-propoxymethyl)guanine in patients with AIDS and other immunodeficiencies. Collaborative DHPG Treatment Study Group N. Engl. J. Med. 314 13 1986 801 805
2. Anon. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group N. Engl. J. Med. 326 4 1992 213 220
3. Anon. Studies of ocular complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. AIDS Clinical Trials Group (ACTG) Control. Clin. Trials 13 1 1992 22 39
4. Anon. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group N. Engl. J. Med. 326 4 1992 213 220
5. Anon. MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: the Monoclonal Antibody Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group. AIDS Clinical Trials Group Arch. Ophthalmol. 115 12 1997 1528 1536
6. Anon. Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group Ann. Intern. Med. 126 4 1997 264 274
7. Anon. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group Ophthalmology 101 7 1994 1250 1261
8. W.E. Aulitzky, T.F. Schulz, H. Tilg, D. Niederwieser, K. Larcher, L. Ostberg, M. Scriba, J. Martindale, A.C. Stern, and P. Grass Human monoclonal antibodies neutralizing cytomegalovirus (CMV) for prophylaxis of CMV disease: report of a phase I trial in bone marrow transplant recipients J. Infect. Dis. 163 6 1991 1344 1347
9. W.E. Aulitzky, T.F. Schulz, H. Tilg, D. Niederwieser, K. Larcher, L. Ostberg, M. Scriba, J. Martindale, A.C. Stern, and P. Grass Human monoclonal antibodies neutralizing cytomegalovirus (CMV) for prophylaxis of CMV disease: report of a phase I trial in bone marrow transplant recipients J. Infect. Dis. 163 6 1991 1344 1347
10. M. Boeckh, R.A. Bowden, B. Storer, N.J. Chao, R. Spielberger, D.K. Tierney, G. Gallez-Hawkins, T. Cunningham, K.G. Blume, D. Levitt, and J.A. Zaia Randomized, placebo-controlled, double-blind study of a cytomegalovirus-specific monoclonal antibody (MSL-109) for prevention of cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation Biol. Blood Marrow Transplant. 7 6 2001 343 351
11. R.A. Bowden, L.D. Fisher, K. Rogers, M. Cays, and J.D. Meyers Cytomegalovirus (CMV)-specific intravenous immunoglobulin for the prevention of primary CMV infection and disease after marrow transplant J. Infect. Dis. 164 3 1991 483 487
12. W.J. Britt, and M. Mach Human cytomegalovirus glycoproteins Intervirology 39 5/6 1996 401 412
13. W.L. Drew Cytomegalovirus disease in the highly active antiretroviral therapy era Curr. Infect. Dis. Rep. 5 3 2003 257 265
14. W.R. Drobyski, M. Gottlieb, D. Carrigan, L. Ostberg, M. Grebenau, H. Schran, P. Magid, P. Ehrlich, P.I. Nadler, and R.C. Ash Phase I study of safety and pharmacokinetics of a human anticytomegalovirus monoclonal antibody in allogeneic bone marrow transplant recipients Transplantation 51 6 1991 1190 1196
15. P.R. Egbert, R.B. Pollard, J.G. Gallagher, and T.C. Merigan Cytomegalovirus retinitis in immunosuppressed hosts. II. Ocular manifestations Ann. Intern. Med. 93 5 1980 664 670
16. J.E. Gallant, R.D. Moore, D.D. Richman, J. Keruly, R.E. Chaisson The Zidovudine Epidemiology Study Group Incidence and natural history of cytomegalovirus disease in patients with advanced human immunodeficiency virus disease treated with zidovudine J. Infect. Dis. 166 6 1992 1223 1227
17. A.M. Gilpin, J.T. Holbrook, D.A. Jabs, and C.L. Meinert Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial Control. Clin. Trials 24 1 2003 92 98
18. M.J. Gorensek, R.W. Stewart, T.F. Keys, M.C. McHenry, T. Babiak, and M. Goormastic Symptomatic cytomegalovirus infection as a significant risk factor for major infections after cardiac transplantation J. Infect. Dis. 158 4 1988 884 887
19. M.J. Gorensek, R.W. Stewart, T.F. Keys, M.C. McHenry, and M. Goormastic A multivariate analysis of the risk of cytomegalovirus infection in heart transplant recipients J. Infect. Dis. 157 3 1988 515 522
20. V.F. Hoffman, and D.J. Skiest Therapeutic developments in cytomegalovirus retinitis Exp. Opin. Investig. Drugs 9 2 2000 207 220
21. D.A. Jabs, A.M. Gilpin, Y.I. Min, A. Erice, J.H. Kempen, and T.C. Quinn HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial AIDS 16 6 2002 877 887
22. M.A. Jacobson, M. Zegans, P.R. Pavan, J.J. O'Donnell, F. Sattler, N. Rao, S. Owens, and R. Pollard Cytomegalovirus retinitis after initiation of highly active antiretroviral therapy Lancet 349 9063 1997 1443 1445
23. S.C. Johnson, C.A. Benson, D.W. Johnson, and A. Weinberg Recurrences of cytomegalovirus retinitis in a human immunodeficiency virus-infected patient, despite potent antiretroviral therapy and apparent immune reconstitution Clin. Infect. Dis. 32 5 2001 815 819
24. B.D. Kuppermann, J.G. Petty, D.D. Richman, W.C. Mathews, S.C. Fullerton, L.S. Rickman, and W.R. Freeman Correlation between CD4+ counts and prevalence of cytomegalovirus retinitis and human immunodeficiency virus-related noninfectious retinal vasculopathy in patients with acquired immunodeficiency syndrome Am. J. Ophthalmol. 115 5 1993 575 582
25. F. Lakeman, C. Blevins, R. Whitley, and M.D. Tolpin In vitro neutralization of cytomegalovirus strain by a human monoclonal antibody, MSL-109 (abstract) Antiviral Res. 15 Suppl. 1 1991 77
26. D. Lilleri, G. Piccinini, F. Baldanti, E. Seminari, D. Galloni, and G. Gerna Multiple relapses of human cytomegalovirus retinitis during HAART in an AIDS patient with reconstitution of CD4+ T cell count in the absence of HCMV-specific CD4+ T cell response J. Clin. Virol. 26 1 2003 95 100
27. J. Mallolas, J. Arrizabalaga, M. Lonca, J.M. Gatell, A. Adan, E. Martinez-Chamorro, C. Tortajada, F. Rodriguez-Arrondo, A. Blanco, A. Guelar, and E. Soriano Cytomegalovirus disease in HIV-1-infected patients treated with protease inhibitors AIDS 11 14 1997 1785 1787
28. J.D. Meyers, J. Leszczynski, J.A. Zaia, N. Flournoy, B. Newton, D.R. Snydman, G.G. Wright, M.J. Levin, and E.D. Thomas Prevention of cytomegalovirus infection by cytomegalovirus immune globulin after marrow transplantation Ann. Intern. Med. 98 4 1983 442 446
29. E.L. Murphy, A.C. Collier, L.A. Kalish, S.F. Assmann, M.F. Para, T.P. Flanigan, P.N. Kumar, L. Mintz, F.R. Wallach, and G.J. Nemo Highly active antiretroviral therapy decreases mortality and morbidity in patients with advanced HIV disease Ann. Intern. Med. 135 1 2001 17 26
30. M. Nokta, M.D. Tolpin, P.I. Nadler, and R.B. Pollard Human monoclonal anti-cytomegalovirus (CMV) antibody (MSL 109): enhancement of in vitro foscarnet- and ganciclovir-induced inhibition of CMV replication Antiviral Res. 24 1 1994 17 26
31. L. Ostberg Human monoclonal antibodies in transplantation. Transplant. Proc. 24 4, Suppl. 2 1992 26 30
32. L. Ostberg, and C. Queen Human and humanized monoclonal antibodies: preclinical studies and clinical experience Biochem. Soc. Trans. 23 4 1995 1038 1043
33. P. Pertel, R. Hirschtick, J. Phair, J. Chmiel, L. Poggensee, and R. Murphy Risk of developing cytomegalovirus retinitis in persons infected with the human immunodeficiency virus J. Acquir. Immune Defic. Syndr. 5 11 1992 1069 1074
34. R. Pollard, M. Nokta, P. Pappas, M. Holloway, M.J. Borucki, D.L. Wood, A.M. Zitelli, M.D. Tolpin, P.I. Nadler, and R. Whitley A phase I/IIA study of a human monoclonal anti-cytomegalovirus antibody in patients with AIDS Antiviral Res. 17 1992 111
35. G.V. Quinnan Jr., N. Kirmani, A.H. Rook, J.F. Manischewitz, L. Jackson, G. Moreschi, G.W. Santos, R. Saral, and W.H. Burns Cytotoxic T cells in cytomegalovirus infection: HLA-restricted T-lymphocyte and non-T-lymphocyte cytotoxic responses correlate with recovery from cytomegalovirus infection in bone-marrow-transplant recipients N. Engl. J. Med. 307 1 1982 7 13
36. P. Reusser, S.R. Riddell, J.D. Meyers, and P.D. Greenberg Cytotoxic T-lymphocyte response to cytomegalovirus after human allogeneic bone marrow transplantation: pattern of recovery and correlation with cytomegalovirus infection and disease Blood 78 5 1991 1373 1380
37. R.H. Rubin Cytomegalovirus in solid organ transplantation. Transpl. Infect Dis. 3 Suppl. 2 2001 1 5
38. K. Schoppel, B. Kropff, C. Schmidt, R. Vornhagen, and M. Mach The humoral immune response against human cytomegalovirus is characterized by a delayed synthesis of glycoprotein-specific antibodies J. Infect. Dis. 175 3 1997 533 544
39. R.F. See, and N.A. Rao Cytomegalovirus retinitis in the era of combined highly active antiretroviral therapy Ophthalmol. Clin. North Am. 15 4 2002 529 536 viii
40. S.A. Shelburne III, R.J. Hamill, M.C. Rodriguez-Barradas, S.B. Greenberg, R.L. Atmar, D.W. Musher, J.C. Gathe Jr., F. Visnegarwala, and B.W. Trautner Immune reconstitution inflammatory syndrome: emergence of a unique syndrome during highly active antiretroviral therapy Medicine (Baltimore) 81 3 2002 213 227
41. D.R. Snydman Ganciclovir therapy for cytomegalovirus disease associated with renal transplants Rev. Infect. Dis. 10 Suppl. 3 1988 S554 S562
42. S.A. Spector, T. Weingeist, R.B. Pollard, D.T. Dieterich, T. Samo, C.A. Benson, D.F. Busch, W.R. Freeman, P. Montague, H.J. Kaplan AIDS Clinical Trials Group and Cytomegalovirus Cooperative Study Group A randomized, controlled study of intravenous ganciclovir therapy for cytomegalovirus peripheral retinitis in patients with AIDS J. Infect. Dis. 168 3 1993 557 563
43. M. Urban, M. Klein, W.J. Britt, E. Hassfurther, and M. Mach Glycoprotein H of human cytomegalovirus is a major antigen for the neutralizing humoral immune response J. Gen. Virol. 77 Pt. 7 1996 1537 1547
44. S.L. Walmsley, E. Chew, S.E. Read, H. Vellend, I. Salit, A. Rachlis, and M.M. Fanning Treatment of cytomegalovirus retinitis with trisodium phosphonoformate hexahydrate (Foscarnet) J. Infect. Dis. 157 3 1988 569 572
45. A. Weinberg, D.A. Wohl, R.J. Barrett, and H.C. van der Inconsistent reconstitution of cytomegalovirus-specific cell-mediated immunity in human immunodeficiency virus-infected patients receiving highly active antiretroviral therapy J. Infect. Dis. 184 6 2001 707 712
46. J.A. Zaia Prevention and management of CMV-related problems after hematopoietic stem cell transplantation Bone Marrow Transplant. 29 8 2002 633 638