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

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 tria...

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Published in:Clinical microbiology and infection 2015-05, Vol.21 (5), p.510.e1-510.e9
Main Authors: Nozza, S., Galli, L., Antinori, A., Chiappetta, S., Mazzotta, F., Zaccarelli, M., Ottou, S., De Battista, D., Pogliaghi, M., Di Pietro, M., Malnati, M., Ripa, M., Bonora, S., Lazzarin, A.
Format: Article
Language:English
Subjects:
Adult
Anti-HIV Agents - administration & dosage
Antiretroviral therapy
Antiretroviral Therapy, Highly Active - methods
CD4 Lymphocyte Count
Cyclohexanes - administration & dosage
DNA, Viral - blood
Drug Combinations
Female
HIV Infections - drug therapy
HIV-1 - isolation & purification
human immunodeficiency virus
Humans
Lopinavir - administration & dosage
Male
maraviroc
naive patients
nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimen
Prospective Studies
Ritonavir - administration & dosage
Treatment Outcome
Triazoles - administration & dosage
Viral Load
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Summary: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 
ISSN:1198-743X
1469-0691
DOI:10.1016/j.cmi.2014.12.006