Therapeutic immunization with an inactivated HIV-1 immunogen plus antiretrovirals versus antiretroviral therapy alone in asymptomatic HIV-infected subjects

被引:16
作者
Fernandez-Cruz, E
Moreno, S
Navarro, J
Clotet, B
Bouza, E
Carbone, J
Peña, JM
Molina, JP
Podzamczer, D
Rubio, R
Ocaña, I
Pulido, F
Viciana, P
Maradona, JA
Blazquez, R
Barros, C
Quereda, C
Rodriguez-Sainz, C
Gil, J
Abad, ML
Díaz, L
Cantó, C
Muñoz, MA
Ferrer, E
Jou, A
Sirera, G
Díaz, M
Lopez, F
Gatell, JM
Gonzalez-Lahoz, J
机构
[1] Univ Madrid, Hosp Gen Gregorio Maranon, Div Immunol, Madrid 28007, Spain
[2] Hosp Ramon & Cajal, E-28034 Madrid, Spain
[3] Hosp Badalona Germans Trias & Pujol, Badalona, Spain
[4] Hosp La Paz, Madrid, Spain
[5] Hosp 12 Octubre, E-28041 Madrid, Spain
[6] Hosp Gen Valle Hebron, Barcelona, Spain
[7] Hosp Virgen Rocio, Seville, Spain
[8] Univ Oviedo, Hosp Cent Asturias, E-33080 Oviedo, Spain
[9] Hosp Morales Meseguer, Murcia, Spain
[10] Nufarm 21, Madrid, Spain
[11] Hosp Clin Barcelona, Barcelona, Spain
[12] Inst Salud Carlos III, Madrid, Spain
关键词
HIV-1; immunogen; viral load; therapeutic vaccination;
D O I
10.1016/j.vaccine.2004.03.040
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
To determine whether the addition of an inactivated-gp120-depleted HIV-1 Immunogen to antiretrovirals (ARTs) conferred a beneficial effect on delaying time to virologic failure relative to that obtained by ARTs alone, a phase II clinical trial was performed in 243 asymptomatic, ART naive, HIV-1 seropositive adults. The Cox model showed that HIV-1 Immunogen treatment was associated with a 34% decrease in the risk of virologic failure (P = 0.056). When the analysis incorporated baseline HIV-RNA stratification the risk of virologic failure in the HIV-1 Immunogen Arm was significantly reduced a 37% compared to the IFA placebo Arm (P = 0.034). The data suggest that therapeutic immunization plus ARTs could influence virologic control. (C) 2004 Elsevier Ltd. All rights reserved.
引用
收藏
页码:2966 / 2973
页数:8
相关论文
共 30 条
[1]  
BLOWER SM, 2003, AIDSSCIENCE, V3
[2]   HIV type 1 isolate Z321, the strain used to make a therapeutic HIV type 1 immunogen, is intersubtype recombinant [J].
Choi, DJ ;
Dube, S ;
Spicer, TP ;
Slade, HB ;
Jensen, FC ;
Poiesz, BJ .
AIDS RESEARCH AND HUMAN RETROVIRUSES, 1997, 13 (04) :357-361
[3]   IN-VIVO EMERGENCE OF HIV-1 VARIANTS RESISTANT TO MULTIPLE PROTEASE INHIBITORS [J].
CONDRA, JH ;
SCHLEIF, WA ;
BLAHY, OM ;
GABRYELSKI, LJ ;
GRAHAM, DJ ;
QUINTERO, JC ;
RHODES, A ;
ROBBINS, HL ;
ROTH, E ;
SHIVAPRAKASH, M ;
TITUS, D ;
YANG, T ;
TEPPLER, H ;
SQUIRES, KE ;
DEUTSCH, PJ ;
EMINI, EA .
NATURE, 1995, 374 (6522) :569-571
[4]   Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy - A randomized controlled trial [J].
Davey, RT ;
Murphy, RL ;
Graziano, FM ;
Boswell, SL ;
Pavia, AT ;
Cancio, M ;
Nadler, JP ;
Chaitt, DG ;
Dewar, RL ;
Sahner, DK ;
Duliege, AM ;
Capra, WB ;
Leong, WP ;
Giedlin, MA ;
Lane, HC ;
Kahn, JO .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 284 (02) :183-189
[5]   Latent infection of CD4+ T cells provides a mechanism for lifelong persistence of HIV-1, even in patients on effective combination therapy [J].
Finzi, D ;
Blankson, J ;
Siliciano, JD ;
Margolick, JB ;
Chadwick, K ;
Pierson, T ;
Smith, K ;
Lisziewicz, J ;
Lori, F ;
Flexner, C ;
Quinn, TC ;
Chaisson, RE ;
Rosenberg, E ;
Walker, B ;
Gange, S ;
Gallant, J ;
Siliciano, RF .
NATURE MEDICINE, 1999, 5 (05) :512-517
[6]   What constitutes efficacy for a human immunodeficiency virus vaccine that ameliorates viremia: Issues involving surrogate end points in phase 3 trials [J].
Gilbert, PB ;
DeGruttola, VG ;
Hudgens, MG ;
Self, SG ;
Hammer, SM ;
Corey, L .
JOURNAL OF INFECTIOUS DISEASES, 2003, 188 (02) :179-193
[7]   Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 106/L CD4 cell counts -: A randomized controlled trial [J].
Kahn, JO ;
Cherng, DW ;
Mayer, K ;
Murray, H ;
Lagakos, S .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 284 (17) :2193-2202
[8]   EFFECT OF GAMMA-IRRADIATION ON THE HUMAN IMMUNODEFICIENCY VIRUS AND HUMAN COAGULATION PROTEINS [J].
KITCHEN, AD ;
MANN, GF ;
HARRISON, JF ;
ZUCKERMAN, AJ .
VOX SANGUINIS, 1989, 56 (04) :223-229
[9]   Nadir CD4+ T-cell count and numbers of CD28+ CD4+ T-cells predict functional responses to immunizations in chronic HIV-1 infection [J].
Lange, CG ;
Lederman, MM ;
Medvik, K ;
Asaad, R ;
Wild, M ;
Kalayjian, R ;
Valdez, H .
AIDS, 2003, 17 (14) :2015-2023
[10]   Safety and immunogenicity of REMUNE™ in HIV-infected Thai subjects [J].
Limsuwan, A ;
Churdboonchart, V ;
Moss, RB ;
Sirawaraporn, W ;
Sutthent, R ;
Smutharaks, B ;
Glidden, D ;
Trauger, R ;
Theofan, G ;
Carlo, D .
VACCINE, 1998, 16 (2-3) :142-149