Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119).
BACKGROUND
Interleukin (IL)-2 increases CD4 T cell counts when combined with antiretroviral therapy (ART). Whether IL-2 alone can increase CD4 cell counts is unknown.


METHODS
A total of 130 adults who had a CD4 cell count of 300-500 cells/microL (and, thus, were not eligible to receive ART) were randomized to receive either intermittent IL-2 therapy or no treatment. The primary end point was a drop in CD4 cell count to <300 cells/microL, initiation of ART, the occurrence of an AIDS-defining event, or death.


RESULTS
Through week 96, 35% of the patients in the IL-2 arm and 59% in the control arm reached the primary end point (P = .008). Median changes from baseline in the IL-2 and control arms were +51 and -64 cells/microL, respectively, for CD4 cell count (P < .001) and were +0.02 and +0.04 log(10) copies/mL, respectively, for plasma viral load (P = .93). Among patients with a baseline viral load <4.5 log(10) copies/mL, 64% in the IL-2 arm and 10% in the control arm did not reach the primary end point through week 150 (P < .001), and the time to ART initiation was deferred by 92 weeks in the IL-2 arm. The incidences of an AIDS-defining event, death, and grade 3 or 4 adverse events were similar between study arms.


CONCLUSIONS
IL-2 increased CD4 cell counts without affecting HIV replication and allowed the initiation of ART to be deferred.


BACKGROUND
ClinicalTrials.gov identifier: NCT00120185 .
Molina
Jean-Michel
JM
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, France. jean-michel.molina@sls.aphp.fr
Levy
Yves
Y
Fournier
Isabelle
I
Hamonic
Stephanie
S
Bentata
Michèle
M
Beck-Wirth
Genevieve
G
Gougeon
Marie-Lise
ML
Venet
Alain
A
Madelaine
Isabelle
I
Sereni
Daniel
D
Jeanblanc
François
F
Boulet
Thomas
T
Simon
François
F
Aboulker
Jean-Pierre
JP
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014779:Virus Replication / Q000187:drug effects; D055815:Young Adult
D019380:Anti-HIV Agents; D007376:Interleukin-2