Switching the third drug of antiretroviral therapy to maraviroc in aviraemic subjects: A pilot, prospective, randomized clinical trial

Anna Bonjoch, Christian Pou, Núria Pérez-Álvarez, Rocío Bellido, Maria Casadella, Jordi Puig, Marc Noguera-Julian, Bonaventura Clotet, Eugènia Negredo, Roger Paredes

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20 Citations (Scopus)

Abstract

To evaluate the safety and efficacy of switching the third drug of antiretroviral treatment to maraviroc in aviraemic subjects infected with R5 HIV. Patients and methods: This is a pilot, prospective, randomized clinical trial (ClinicalTrials ID: NCT00966329). Eighty HIV-1-infected aviraemic adults on stable antiretroviral treatment for ≥1 year and no antiretroviral drug resistance were screened for the presence of non-R5 HIV by triplicate proviral V3 population sequencing. From them, 30 subjects with R5 HIV-1 were randomized 1:1 to switch the non-nucleoside reverse transcriptase inhibitor or ritonavir-boosted protease inhibitor to maraviroc (n=15) or to continue the same antiretroviral treatment (controls, n=15). The principal endpoint was the proportion of subjects with HIV-1 RNA <50 copies/ mL at week 48. Ultrasensitive proviral HIV-1 tropism testing (454 sequencing) was performed retrospectively at weeks 0, 4, 12, 24, 36 and 48. Results: One subject in the maraviroc arm and one control had non-R5 HIV in proviral DNA by retrospective 454 sequencing. The subject receiving maraviroc was the only individual to develop virological failure. However, plasma HIV at failure was R5. Switching to maraviroc was well tolerated and associated with small, but statistically significant, declines in total, high-density lipoprotein and low-density lipoprotein cholesterol. Median (IQR) triglyceride [1 (0.67-1.22) versus 1.6 (1.4-3.1) mmol/L, P=0.003] and total cholesterol [4.3 (4.1-4.72) versus 5.4 (4-5.7) mmol/L, P=0.059] values were lower in the maraviroc arm than in controls at week 48. Conclusions: In this pilot, prospective, randomized clinical trial, switching the third drug to maraviroc was safe, efficacious and improved lipid parameters. ©The Author 2013.
Original languageEnglish
Pages (from-to)1382-1386
JournalJournal of Antimicrobial Chemotherapy
Volume68
Issue number6
DOIs
Publication statusPublished - 1 Jun 2013

Keywords

  • HIV
  • Ultrasensitive proviral HIV-1 tropism testing
  • Virally suppressed patients

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