title: Sustained control of viremia following therapeutic immunization in chronically HIV-1-infected individuals.
abstract: OBJECTIVE
  Viral rebounds inevitably follow interruption of antiretroviral treatment in HIV-1-infected individuals. The randomized ANRS 093 aimed at investigating whether a therapeutic immunization was effective in containing the long-term viral replication following discontinuation of antiretroviral drugs in patients.
  
  
  METHODS
  Seventy HIV-1-infected patients effectively treated with antiretroviral drugs were randomized to continue treatment alone or in combination with four boosts of ALVAC 1433 and HIV-LIPO-6T vaccines followed by three cycles of subcutaneous interleukin-2. The impact of vaccination on viral replication was assessed by interrupting antiretroviral drugs first at week 40 and thereafter during follow-up until week 100. Antiretroviral drugs were re-initiated according to predefined criteria.
  
  
  RESULTS
  The median cumulative time (days) off treatment was greater in the vaccine group (177) than in the control group (89) (P = 0.01). The proportion of time (mean, SE) without antivirals per-patient was 42.8% (5.1) and 26.5% (4.2) in the vaccine and control groups, respectively (P = 0.005). Viremia (median log10 copies/ml), 4 weeks following the first, second and third treatment interruption was higher in control patients (4.81, 4.44, 4.53) in comparison with vaccinated patients (4.48, 4.00, 3.66) (P = 0.42, 0.015 and 0.024, respectively). HIV-specific CD4 and CD8 T-cell responses elicited by the therapeutic immunization strongly correlated with the reduction of the time of antiviral therapy (P = 0.0027 and 0.016, respectively).
  
  
  CONCLUSIONS
  Our findings provide evidence that therapeutic immunization significantly impacts on HIV-1 replication. This translated into a decrease of up to 40% in the duration of exposure to antiretroviral drugs over 15 months of patients' follow-up.
authors.affiliation: Hôpital Henri Mondor, 51 av Mal de Lattre de Tassigny, 94010 Créteil, France. yves.levy@hmn.ap-hop-paris.fr
authors.forename: Yves
authors.initials: Y
authors.lastname: Lévy
authors.forename: Christine
authors.initials: C
authors.lastname: Durier
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Lascaux
authors.forename: Vincent
authors.initials: V
authors.lastname: Meiffrédy
authors.forename: Hanne
authors.initials: H
authors.lastname: Gahéry-Ségard
authors.forename: Cécile
authors.initials: C
authors.lastname: Goujard
authors.forename: Christine
authors.initials: C
authors.lastname: Rouzioux
authors.forename: Martine
authors.initials: M
authors.lastname: Resch
authors.forename: Jean-Gérard
authors.initials: JG
authors.lastname: Guillet
authors.forename: Michel
authors.initials: M
authors.lastname: Kazatchkine
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Delfraissy
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
mesh_terms: D016915:AIDS Vaccines; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology / Q000821:virology; D002908:Chronic Disease; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D014765:Viral Vaccines; D014766:Viremia / Q000276:immunology / Q000517:prevention & control*
chemical_list: D016915:AIDS Vaccines; C078788:ALVAC vaccine; C514156:HIV-LIPO-6T; D014765:Viral Vaccines