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Proposal 1079

Title of the Proposed Research

The effects of maraviroc versus efavirenz in combination with zidovudine/abacavir on the CD4/CD8 ratio in treatment-naïve HIV-infected individuals.

Lead Researcher

Sergio Serrano-Villar, MD PhD

Affiliation

Deparment of Infectious Diseases
University Hospital Ramón y Cajal
Madrid, Spain.

Funding Source

None

Potential Conflicts of Interest

Lead Researcher: None
Researcher 1: SM has received grants and consulting fee from ViiV-Healthcare
Researcher 2: None

Management of Real or Potential Conflicts of Interest
Any potential conflict of interest will be disclosed when data are presented and published.

Data Sharing Agreement Date

31 October 2014

Lay Summary

A low CD4/CD8 ratio is considered a surrogate marker of immunosenescence and is an independent predictor of all-cause mortality. We have recently described in long-term virally suppressed HIV infected subjects a negative correlation between the CD4/CD8 ratio and inflammation/inmmunosenescence. We also observed that is independently associated with surrogate markers of age-associated disease and non-AIDS-related morbidity and mortality. Collectively, these studies suggest that a low CD4/CD8 ratio despite otherwise effective ART might identify a new clinical phenotype of patients needed of novel interventions. Given the strong clinical implications the impact of different regimens on the CD4/CD8 ratio recovery needs to be analyzed. For this purpose, we herein request the MERIT study, a randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase (240-week follow-up) to assess the efficacy of zidovudine/lamivudine in combination with maraviroc or efavirenz in treatment–naïve patients.

Study Data Provided

Study A4001026: A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation