title: Structured treatment interruptions in primary HIV-1 infection: the ANRS 100 PRIMSTOP trial.
abstract: BACKGROUND
  Whether structured treatment interruptions (STIs) can induce anti-HIV immune response and control HIV replication following discontinuation of highly active antiretroviral therapy (HAART) in patients with primary HIV infection is controversial.
  
  
  METHODS
  In this multicenter, prospective trial, patients with early symptomatic primary HIV infection were given HAART continuously for 34 weeks. Afterward, patients with plasma viral load (PVL) <50 copies/mL entered the STI phase, which consisted of 3 consecutive periods of 2, 4, and 8 weeks off HAART, each separated by 12 weeks on HAART. HAART was permanently stopped at week 84 and patients were followed up for 24 weeks. The primary endpoint for definition of virologic success was a PVL <50 copies/mL during the 6 months following HAART discontinuation.
  
  
  RESULTS
  Of the 29 patients enrolled, 26 completed the trial. Six months after HAART discontinuation, only 1 patient (3.8%, 95% CI: 0.1% to 19.6%) had PVL <50 copies/mL, whereas 6 of 26 (23.1%, 95% CI: 9.0% to 43.7%) had PVL <1000 copies/mL. Female gender was the only parameter significantly associated with a PVL <1000 copies/mL. No other parameter, either at baseline or before HAART discontinuation, predicted virologic success at week 108. A major protease inhibitor resistance mutation (L90M) developed in 3 patients.
  
  
  CONCLUSIONS
  This trial failed to confirm that a significant proportion of patients with primary HIV infection can maintain suppression of viremia after a sequence of HAART/STIs followed by HAART discontinuation.
authors.affiliation: Department of Infectious Diseases and EA 3186, University Medical Center of Besançon and Université de Franche-Comté, Villejuif, France. bruno.hoen@univ-fcomte.fr
authors.forename: Bruno
authors.initials: B
authors.lastname: Hoen
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fournier
authors.forename: Christine
authors.initials: C
authors.lastname: Lacabaratz
authors.forename: Marianne
authors.initials: M
authors.lastname: Burgard
authors.forename: Isabelle
authors.initials: I
authors.lastname: Charreau
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Chaix
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Livrozet
authors.forename: Alain
authors.initials: A
authors.lastname: Venet
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
authors.forename: Christine
authors.initials: C
authors.lastname: Rouzioux
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D024882:Drug Resistance, Viral; D005260:Female; D005602:France; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008297:Male; D010349:Patient Compliance; D012367:RNA, Viral / Q000032:analysis; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D012367:RNA, Viral