Maraviroc in addition to cART during primary HIV infection: Results from MAIN randomized clinical trial and 96-weeks follow-up |
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| Affiliation: | 1. IRCCS Ospedale San Raffaele, Department of Infectious and Tropical Diseases, Milan, Italy;2. Ospedale San Gerardo, Division of Infectious Diseases, Monza, Italy;3. Università Vita-Salute San Raffaele, Milan, Italy;1. School of Naval Architecture, Ocean and Civil Engineering, Shanghai Jiao Tong University, Shanghai, China;2. Department of Radiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China;3. Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;1. Department of Neurosurgery, University of Rochester Medical Center, Rochester, New York, USA;2. Indiana University School of Medicine, Indianapolis, Indiana, USA;3. Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA;1. Dermatology Service, Hospital del Mar, Parc de Salut Mar, Universitat Autonoma Barcelona [Autonomous University of Barcelona], Barcelona, Spain;2. Allergology Department, Clínica Universidad de Navarra [University Clinic of Navarra], Pamplona, Spain;3. Pneumology and Allergy Service, Hospital Clinic, University of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) [August Pi i Sunyer Biomedical Research Institute], Barcelona, Spain;4. Allergology Service, Hospital Universitario Basurto [Basurto University Hospital], Bilbao, Spain;5. Allergology Section, Medicine Department, Hospital Vall d’Hebron, Universitat Autònoma de Barcelona [Autonomous University of Barcelona], Barcelona, Spain;6. Dermatology Service, Hospital Universitario 12 de Octubre [University Hospital 12 of October], Madrid, Spain;7. Dermatology Service, Hospital General Universitario de Alicante [University of Alicante General Hospital], Alicante, Spain;8. Allergology Service, Fundación Jiménez Diaz [Jiménez Diaz Foundation], Madrid, Spain;9. Dermatology Service, Hospital Arnau de Vilanova, Valencia, Spain;10. Pneumology and Allergy Service, Hospital Clinic (ICT), University of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) [August Pi i Sunyer Biomedical Research Institute], Barcelona, Spain;1. Department of Paediatrics, Kimberley Hospital, Kimberley, South Africa;2. Department of Paediatrics, Peter Medawar Building, South Parks Road, Oxford OX1 3SY, UK;3. Department of Infectious Diseases and Microbiology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, UK;4. Department of Medical Microbiology and Virology, National Health Laboratory Service, University of the Free State, Bloemfontein, South Africa;5. Nuffield Department of Medicine, Peter Medawar Building, South Parks Road, Oxford OX1 3SY, UK;1. Division of Cardiology, Duke Global Health Institute, Duke Clinical Research Institute, Duke University, 2400 Pratt Street, Durham, NC 27705, USA;2. Feinberg School of Medicine, Northwestern University, 420 East Superior Street, Chicago, IL 60611, USA |
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| Abstract: | BackgroundMulti-targeted treatment strategies including maraviroc (MVC) during Primary HIV Infection (PHI) may benefit from the immune-modulatory properties of this CCR5-inhibitor.ObjectivesWe 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.Study designThe 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.ResultsTwenty-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.ConclusionsThe 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. |
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| Keywords: | HIV Primary HIV infection Maraviroc CD4 |
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