Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.
BACKGROUND
The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4(+) counts compared to no therapy.


METHODS
Participants not on continuous ART with > or = 300 CD4(+) cells/mm(3) were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4(+) counts, HIV RNA, and HIV progression events were collected monthly.


RESULTS
A total of 267 participants were randomized. At week 32, the mean CD4(+) count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p = 0.009).


CONCLUSIONS
IL-2 alone or with peri-cycle HAART increases CD4(+) counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4(+) cells.


BACKGROUND
ClinicalTrials.gov NCT00110812.
Tavel
Jorge A
JA
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Babiker
Abdel
A
Fox
Lawrence
L
Gey
Daniela
D
Lopardo
Gustavo
G
Markowitz
Norman
N
Paton
Nicholas
N
Wentworth
Deborah
D
Wyman
Nicole
N
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate; D018791:CD4 Lymphocyte Count; D002219:Carbamates / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000139:chemically induced; D005663:Furans; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D061466:Lopinavir; D008297:Male; D009325:Nausea / Q000139:chemically induced; D009842:Oligopeptides / Q000627:therapeutic use; D009894:Opportunistic Infections / Q000139:chemically induced; D010755:Organophosphates / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011744:Pyrimidinones / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D013449:Sulfonamides / Q000627:therapeutic use; D016896:Treatment Outcome
D019380:Anti-HIV Agents; D002219:Carbamates; D005663:Furans; D007376:Interleukin-2; D009842:Oligopeptides; D010755:Organophosphates; D011725:Pyridines; D011744:Pyrimidinones; D013449:Sulfonamides; D061466:Lopinavir; D000069446:Atazanavir Sulfate; D019438:Ritonavir; C426859:fosamprenavir