Therapeutic immunization with an inactivated HIV-1 Immunogen plus antiretrovirals versus antiretroviral therapy alone in asymptomatic HIV-infected subjects.
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 naïve, 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.
Fernandez-Cruz
E
E
Division of Immunology, Hospital General Universitario "Gregorio Marañon", Dr. Esquerdo 46, 28007 Madrid, Spain. efernandezc.hgugm@salud.madrid.org
Moreno
S
S
Navarro
J
J
Clotet
B
B
Bouza
E
E
Carbone
J
J
Peña
J M
JM
Pérez Molina
J
J
Podzamczer
D
D
Rubio
R
R
Ocaña
I
I
Pulido
F
F
Viciana
P
P
Maradona
J A
JA
Blazquez
R
R
Barros
C
C
Quereda
C
C
Rodriguez-Sainz
C
C
Gil
J
J
Abad
M L
ML
Díaz
L
L
Cantó
C
C
Muñoz
M A
MA
Ferrer
E
E
Jou
A
A
Sirera
G
G
Díaz
M
M
Lopez
F
F
Gatell
J M
JM
Gonzalez-Lahoz
J
J
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018925:Chemokines / Q000378:metabolism; D003131:Combined Modality Therapy; D023381:Endpoint Determination; D005260:Female; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology / Q000628:therapy*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects / Q000276:immunology; D007371:Interferon-gamma / Q000096:biosynthesis / Q000235:genetics; D008232:Lymphoproliferative Disorders / Q000276:immunology / Q000473:pathology; D008297:Male; D006377:T-Lymphocytes, Helper-Inducer / Q000276:immunology; D018417:Th1 Cells / Q000276:immunology; D015164:Vaccines, Inactivated / Q000627:therapeutic use
D016915:AIDS Vaccines; D019380:Anti-HIV Agents; D018925:Chemokines; D015699:HIV Envelope Protein gp120; D015164:Vaccines, Inactivated; D007371:Interferon-gamma