title: Maraviroc in addition to cART during primary HIV infection: Results from MAIN randomized clinical trial and 96-weeks follow-up.
abstract: Multi-targeted treatment strategies including maraviroc (MVC) during Primary HIV Infection (PHI) may benefit from the immune-modulatory properties of this CCR5-inhibitor.
  
  
  
  We conducted a proof-of-concept clinical trial aimed at assessing whether maraviroc in addition of a combination antiretroviral therapy (cART) initiated during PHI would improve immunological and virological parameters.
  
  
  
  The MAIN (Maraviroc in HIV Acute INfection) study was a randomized open-label clinical trial (EUDRACT number: 2008-007004-29) which enrolled 29 patients with PHI. Subjects were randomly assigned to receive cART-only (cART), cART+8 weeks of MVC (ST-MVC) or cART+48 weeks of MVC (LT-MVC), regardless of predicted co-receptor usage. After 48 weeks patients in ST-MVC and LT-MVC groups discontinued MVC. Patients were evaluated at week 48 and at week 96 of follow-up to assess differences in CD4 T-cell gain and plasma HIV-RNA.
  
  
  
  Twenty-nine patients were enrolled. Seven patients (24%) had a predicted CXCR4 co-receptor usage. At week 48, 27 patients (93.1%) reached HIV-RNA<50cps/mL. Median CD4 T-cell count increase was 313 cells/μL (p<0.001, Wilcoxon signed-rank test). At multivariate linear regression analysis, LT-MVC arm had the greatest CD4 T-cell increase, while patients in ST-MVC arm had the least gain in CD4 T-cells (p=0.007). At week 96, multivariate analysis showed no associations between former treatment arm and CD4 T-cell gain.
  
  
  
  The MAIN study showed that MVC for 48 weeks in addition to cART during PHI was able to enhance CD4 T-cell gain, regardless of co-receptor usage. After MVC discontinuation, the difference between treatment arms was lost.
authors.affiliation: IRCCS Ospedale San Raffaele, Department of Infectious and Tropical Diseases, Milan, Italy. Electronic address: ripa.marco@hsr.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Ripa
authors.affiliation: IRCCS Ospedale San Raffaele, Department of Infectious and Tropical Diseases, Milan, Italy.
authors.forename: Manuela
authors.initials: M
authors.lastname: Pogliaghi
authors.affiliation: IRCCS Ospedale San Raffaele, Department of Infectious and Tropical Diseases, Milan, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Chiappetta
authors.affiliation: IRCCS Ospedale San Raffaele, Department of Infectious and Tropical Diseases, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Nozza
authors.affiliation: Ospedale San Gerardo, Division of Infectious Diseases, Monza, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Soria
authors.affiliation: Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Coppalini
authors.affiliation: Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Rovelli
authors.affiliation: IRCCS Ospedale San Raffaele, Department of Infectious and Tropical Diseases, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tambussi
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D065100:CCR5 Receptor Antagonists / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003510:Cyclohexanes / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D009419:Nerve Tissue Proteins; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D019562:Viral Load; D000098882:Cocaine- and Amphetamine-Regulated Transcript Protein
chemical_list: D044966:Anti-Retroviral Agents; D065100:CCR5 Receptor Antagonists; D003510:Cyclohexanes; D009419:Nerve Tissue Proteins; D012367:RNA, Viral; D014230:Triazoles; D000098882:Cocaine- and Amphetamine-Regulated Transcript Protein; D000077592:Maraviroc
keywords: CD4; HIV; Maraviroc; Primary HIV infection