TY - JOUR
T1 - Efficacy testing of recombinant human immunodeficiency virus (HIV) gp160 as a therapeutic vaccine in early-stage HIV-1-infected volunteers
AU - Birx, Deborah L.
AU - Loomis-Price, Lawrence D.
AU - Aronson, Naomi
AU - Brundage, John
AU - Davis, Charles
AU - Deyton, Lawrence
AU - Garner, Robin
AU - Gordin, Fred
AU - Henry, David
AU - Holloway, William
AU - Kerkering, Thomas
AU - Luskin-Hawk, Roberta
AU - McNeil, John
AU - Michael, Nelson
AU - Pierce, Phillip Foster
AU - Poretz, Donald
AU - Ratto-Kim, Silvia
AU - Renzullo, Phil
AU - Ruiz, Nancy
AU - Sitz, Karl
AU - Smith, Gale
AU - Tacket, Carol
AU - Thompson, Melanie
AU - Tramont, Edmond
AU - Yangco, Bienvenido
AU - Yarrish, Robert
AU - Redfield, Robert R.
N1 - Funding Information:
Financial support: Cooperative Agreement DAMD17-93-V-3004 between the US Army Medical Research and Materiel Command and the Henry M. Jackson Foundation for the Advancement of Military Medicine and by the National Institutes of Health, Terry Beirn Community Program for Clinical Research on AIDS.
PY - 2000
Y1 - 2000
N2 - A phase II efficacy trial was conducted with recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein gp160 (rgp160) in 608 HIV-infected, asymptomatic volunteers with CD4+ cell counts >400 cells/mm3. During a 5-year study, volunteers received a 6-shot primary series of immunizations with either rgp160 or placebo over 6 months, followed by booster immunizations every 2 months. Repeated vaccination with rgp160 was safe and persistently immunogenic. Adequate follow-up and acquisition of endpoints allowed for definitive interpretation of the trial results. There was no evidence that rgp160 has efficacy as a therapeutic vaccine in early- stage HIV infection, as measured at primary endpoints (50% decline in CD4+ cell count or disease progression to Walter Reed stage 4, 5, or 6) or secondary endpoints. A transient improvement was seen in the secondary CD4 endpoint for the vaccination compared with the placebo arm, but this did not translate into improved clinical outcome.
AB - A phase II efficacy trial was conducted with recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein gp160 (rgp160) in 608 HIV-infected, asymptomatic volunteers with CD4+ cell counts >400 cells/mm3. During a 5-year study, volunteers received a 6-shot primary series of immunizations with either rgp160 or placebo over 6 months, followed by booster immunizations every 2 months. Repeated vaccination with rgp160 was safe and persistently immunogenic. Adequate follow-up and acquisition of endpoints allowed for definitive interpretation of the trial results. There was no evidence that rgp160 has efficacy as a therapeutic vaccine in early- stage HIV infection, as measured at primary endpoints (50% decline in CD4+ cell count or disease progression to Walter Reed stage 4, 5, or 6) or secondary endpoints. A transient improvement was seen in the secondary CD4 endpoint for the vaccination compared with the placebo arm, but this did not translate into improved clinical outcome.
UR - https://www.scopus.com/pages/publications/0034071418
U2 - 10.1086/315308
DO - 10.1086/315308
M3 - Article
C2 - 10720508
AN - SCOPUS:0034071418
SN - 0022-1899
VL - 181
SP - 881
EP - 889
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 3
ER -