title: Maraviroc 150 mg daily plus lopinavir/ritonavir, a nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimen for HIV-infected naive patients: 48-week final results of VEMAN study.
abstract: Non-conventional strategies with nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimens in antiretroviral naive human immunodeficiency virus (HIV) -infected patients have been explored in clinical trials. A prospective, open-label, randomized (1:1), multicentre, proof-of-concept trial (VEMAN study, EUDRACT number 2008-006287-11) was conducted assigning HIV-infected naive patients to once-daily maraviroc plus lopinavir/ritonavir (MVC group) or to tenofovir/emtricitabine plus lopinavir/ritonavir (TDF/FTC group). Clinical and laboratory data were collected at baseline, and after 4, 12, 24, 36 and 48 weeks with the objective to evaluate the 48-week virological and immunological efficacy. HIV-1 DNA load and CD4(+) T-cell subsets were analysed on frozen peripheral blood mononuclear cells collected at baseline, 4 and 48 weeks to explore the trend in HIV reservoirs. Fifty patients were randomized and included in the analysis. During follow up, HIV-1 RNA decreased similarly in both groups and, at week 48, all patients in the MVC group and 22/24 (96%) in the TDF/FTC group had < 50 copies/ml of HIV-1 RNA. CD4(+) trend during follow up was higher in maraviroc-treated patients (MVC group: 286 (183-343) versus TDF/FTC group: 199 (125-285); Mann-Whitney U-test: p 0.033). A significant 48-week increase of CCR5(+) CD4(+) T cells and CD4(+) effector memory cells was observed among maraviroc-treated patients (Wilcoxon signed rank test: p 0.016 and p 0.007, respectively). No significant variations were found in naive and central memory CD4(+) T cells. Among naive patients with an R5 virus, treatment with maraviroc and lopinavir/ritonavir was shown to provide a virological response compared to a triple therapy and a greater immunological benefit.
authors: Department of Infectious Diseases, OSR Scientific Institute, Milan, Italy. Electronic address: silvia.nozza@hsr.it.
authors: S
authors: S
authors: Nozza
authors: Department of Infectious Diseases, OSR Scientific Institute, Milan, Italy.
authors: L
authors: L
authors: Galli
authors: IRCCS INMI Spallanzani, Infectious Disease, Rome, Italy.
authors: A
authors: A
authors: Antinori
authors: Department of Infectious Diseases, OSR Scientific Institute, Milan, Italy; University Vita e Salute San Raffaele, Milan, Italy.
authors: S
authors: S
authors: Chiappetta
authors: Division of Infectious Diseases, Ospedale S.M. Annunziata, Antella, Florence, Italy.
authors: F
authors: F
authors: Mazzotta
authors: IRCCS INMI Spallanzani, Infectious Disease, Rome, Italy.
authors: M
authors: M
authors: Zaccarelli
authors: IRCCS INMI Spallanzani, Infectious Disease, Rome, Italy.
authors: S
authors: S
authors: Ottou
authors: Unit of Human Virology, Division of Immunology, Transplantation and Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors: D
authors: D
authors: De Battista
authors: Department of Infectious Diseases, OSR Scientific Institute, Milan, Italy; University Vita e Salute San Raffaele, Milan, Italy.
authors: M
authors: M
authors: Pogliaghi
authors: Division of Infectious Diseases, Ospedale S.M. Annunziata, Antella, Florence, Italy.
authors: M
authors: M
authors: Di Pietro
authors: Unit of Human Virology, Division of Immunology, Transplantation and Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors: M
authors: M
authors: Malnati
authors: Department of Infectious Diseases, OSR Scientific Institute, Milan, Italy; University Vita e Salute San Raffaele, Milan, Italy.
authors: M
authors: M
authors: Ripa
authors: Unit of Infectious Diseases, Department of Medical Sciences, University of Torino, Italy.
authors: S
authors: S
authors: Bonora
authors: Department of Infectious Diseases, OSR Scientific Institute, Milan, Italy; University Vita e Salute San Raffaele, Milan, Italy.
authors: A
authors: A
authors: Lazzarin
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D003510:Cyclohexanes / Q000008:administration & dosage*; D004279:DNA, Viral / Q000097:blood; D004338:Drug Combinations; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D061466:Lopinavir / Q000008:administration & dosage*; D008297:Male; D000077592:Maraviroc; D011446:Prospective Studies; D019438:Ritonavir / Q000008:administration & dosage*; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage*; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D004279:DNA, Viral; D004338:Drug Combinations; D014230:Triazoles; C558899:lopinavir-ritonavir drug combination; D061466:Lopinavir; D000077592:Maraviroc; D019438:Ritonavir
keywords: Antiretroviral therapy; human immunodeficiency virus; maraviroc; naive patients; nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimen