title: Virological response to short-course maraviroc monotherapy does not predict viral tropism in HIV-1-infected treatment-naive patients.
abstract: OBJECTIVE
  We aimed to evaluate whether virological response to a short course of maraviroc monotherapy could predict HIV-1 tropism.
  
  
  METHODS
  A clinical trial was performed in HIV-1 treatment-naive patients infected with R5- or non-R5-tropic virus determined using the Trofile(®) assay, with >1000 HIV-1 RNA copies/mL. Maraviroc was administered for 10 days. Viral load was measured at baseline and days 4, 7, 10 and 28. The main outcome measurement was the decline in HIV-1 RNA at day 10. The trial was registered in the ClinicalTrials.gov database (NCT01060618; TROPISMVC).
  
  
  RESULTS
  Forty patients [30 R5 and 10 dual/mixed (D/M)] were recruited. There was a significant decrease in HIV-1 RNA after 10 days of maraviroc treatment in patients with R5-tropic virus (median 1.52 log10 RNA copies/mL; 95% CI 1.23-1.63; P < 0.0001), but also in patients with D/M-tropic virus (median 1.62 log(10) RNA copies/mL; 95% CI 0.33-1.88; P = 0.00024). The difference in the HIV-1 RNA decrease (-0.16 log(10) RNA copies/mL; 95% CI -0.53 to 0.22) was not significant (P = 0.410). A decrease >0.5 log(10) RNA copies/mL was found in 96.3% of patients with R5-tropic virus and in 70% of patients with D/M-tropic virus (P = 0.052). The differences were not significant when a decline of 1 log(10) RNA copies/mL was considered (92.6% versus 70%; P = 0.11).
  
  
  CONCLUSIONS
  Treatment-naive patients infected with R5- or D/M-tropic virus have similar virological responses to a short course of maraviroc monotherapy. This clinical test thus cannot be used as a surrogate marker of viral tropism in this population.
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain bhernandeznovoa@gmail.com.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Hernández-Novoa
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: Nadia
authors.initials: N
authors.lastname: Madrid-Elena
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Dronda
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: María J
authors.initials: MJ
authors.lastname: Pérez-Elias
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: José L
authors.initials: JL
authors.lastname: Casado
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Pérez-Molina
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Moreno
authors.affiliation: HIV Unit, Hospital Universitario La Paz-IdiPaz, Madrid, Spain.
authors.forename: Miriam
authors.initials: M
authors.lastname: Estébanez
authors.affiliation: HIV Unit, Hospital Universitario La Paz-IdiPaz, Madrid, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: González
authors.affiliation: Clinical Biostatistics Unit and CIBER ESP, Hospital Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zamora
authors.affiliation: Infectious Diseases, Hospital Universitario Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Moreno
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D003510:Cyclohexanes / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification / Q000502:physiology*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D019562:Viral Load; D056189:Viral Tropism; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D014230:Triazoles; D000077592:Maraviroc
keywords: R5-tropic; clinical trials; dual/mixed-tropic