title: Interruption of antiretroviral therapy initiated during primary HIV-1 infection: impact of a therapeutic vaccination strategy combined with interleukin (IL)-2 compared with IL-2 alone in the ANRS 095 Randomized Study.
abstract: HIV-specific T cell responses play a critical role in the control of infection. We evaluated the impact of immune-based interventions in patients first treated during primary HIV-1 infection (PHI). Forty-three patients were randomized within three groups, to receive either interleukin-2 (IL-2 group), or boosts of ALVAC-HIV (vCP1433) and LIPO-6T followed by interleukin-2 (Vac-IL2 group), compared with no immune intervention (control group), and were monitored for T cell responses. Impact of strategies on viral replication was subsequently assessed during long-term treatment interruption. HIV-specific CD4(+) T cell responses did not change during the study period in immunized patients relative to controls, and vaccination had only a transient effect on interferon-gamma-producing CD8 responses. Viral rebound after treatment interruption was similar in immunized patients and controls. Forty percent of patients had HIV RNA values <10,000 copies/ml 12 weeks after interruption. The cumulative time off treatment represented almost half the total follow-up period. Immunological and virological status during PHI and HIV DNA load at interruption were predictive of the level of viral rebound after treatment interruption, whereas HIV RNA level during PHI and HIV DNA level at interruption were predictive of the time off treatment. Treatment interruption is safe in patients treated early after primary HIV infection. On the basis of this pilot study, HIV immunizations and interleukin-2 appear to have no supplementary benefit.
authors.affiliation: Service de Médecine Interne, Bicêtre Hospital, AP-HP, Le Kremlin Bicêtre, Paris, France. cecile.goujard@bct.aphp.fr
authors.forename: Cécile
authors.initials: C
authors.lastname: Goujard
authors.forename: Fabienne
authors.initials: F
authors.lastname: Marcellin
authors.forename: Houria
authors.initials: H
authors.lastname: Hendel-Chavez
authors.forename: Marianne
authors.initials: M
authors.lastname: Burgard
authors.forename: Vincent
authors.initials: V
authors.lastname: Meiffrédy
authors.forename: Alain
authors.initials: A
authors.lastname: Venet
authors.forename: Christine
authors.initials: C
authors.lastname: Rouzioux
authors.forename: Yacine
authors.initials: Y
authors.lastname: Taoufik
authors.forename: Raphaëlle
authors.initials: R
authors.lastname: El Habib
authors.forename: Maria
authors.initials: M
authors.lastname: Beumont-Mauviel
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
authors.forename: Yves
authors.initials: Y
authors.lastname: Lévy
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Delfraissy
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000276:immunology; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D049109:Cell Proliferation; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000276:immunology; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000276:immunology; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014611:Vaccination
chemical_list: D016915:AIDS Vaccines; C112734:AIDSVAX; D019380:Anti-HIV Agents; D007376:Interleukin-2