title: The mutational archive in proviral DNA does not change during 24 months of continuous or intermittent highly active antiretroviral therapy.
abstract: OBJECTIVE
  The aim of the study was to determine the modifications of the mutational archive in proviral HIV-1 DNA occurring during 24 months of intermittent or continuous highly active antiretroviral therapy (HAART).
  
  
  METHODS
  The study population included subjects enrolled in the Istituto Superiore di Sanità Pulsed Antiretroviral Therapy (ISS PART) clinical trial. All of these patients were on first-line HAART and had plasma HIV-1 RNA below 50 HIV-1 RNA copies/mL. A genotypic resistance test was performed on HIV-1 DNA extracted from peripheral blood mononuclear cells (PBMC) at baseline and after 24 months of follow-up. Resistance-associated mutations (RAMs) were defined according to the International AIDS Society (IAS) USA classification.
  
  
  RESULTS
  Sixty-nine subjects were included in the study [36 enrolled in arm A of the ISS PART (continuous HAART) and 33 enrolled in arm B (intermittent HAART)]. No major modifications of the mutational archive were found in either group after 24 months of follow-up, in terms of both the proportion of subjects with mutations and the total number of mutations.
  
  
  CONCLUSIONS
  In this patient population, the mutational archive in HIV-1 DNA extracted from PBMC was stable for 24 months, irrespective of HAART modality, whether continuous or intermittent.
authors.affiliation: Department of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Rome, Italy. l.palmisano@iss.it
authors.forename: Lucia
authors.initials: L
authors.lastname: Palmisano
authors.forename: M
authors.initials: M
authors.lastname: Giuliano
authors.forename: C M
authors.initials: CM
authors.lastname: Galluzzo
authors.forename: R
authors.initials: R
authors.lastname: Amici
authors.forename: M
authors.initials: M
authors.lastname: Andreotti
authors.forename: L E
authors.initials: LE
authors.lastname: Weimer
authors.forename: M F
authors.initials: MF
authors.lastname: Pirillo
authors.forename: V
authors.initials: V
authors.lastname: Fragola
authors.forename: R
authors.initials: R
authors.lastname: Bucciardini
authors.forename: S
authors.initials: S
authors.lastname: Vella
mesh_terms: D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D004252:DNA Mutational Analysis; D004279:DNA, Viral / Q000187:drug effects / Q000235:genetics*; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000821:virology*; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011533:Proviruses / Q000235:genetics*; D012367:RNA, Viral / Q000032:analysis; D013997:Time Factors; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D004279:DNA, Viral; D012367:RNA, Viral