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Proposal 945

Title of the Proposed Research

The CD4/CD8 Ratio as a Predictor of Non-AIDS Events During Antiretroviral Therapy: Confirmation of its Predictive Value and Impact of Maraviroc in Treatment-Experienced Patients

Lead Researcher

Santiago Moreno

Affiliation

University Hospital Ramón y Cajal
Madrid, Spain

Funding Source

None

Potential Conflicts of Interest

Lead Researcher: ViiV board membership, consultancy and unrestricted grants

Potential conflicts of interest will be disclosed when the research is presented and published.

Data Sharing Agreement Date

23 April 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 of a novel and accessible diagnostic tool that might identify patients at higher risk of disease progression, the predictive importance of the CD4/CD8 ratio during treated HIV infection must be confirmed in large prospective studies. Five-year follow-up data on two large studies of maraviroc in treatment-experienced individuals with a registry of non-AIDS events have been reported, where the prognostic significance of the CD4/CD8 ratio during long-term ART can be conveniently addressed.

Study Data Provided

Study A4001027: Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Study A4001028: Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Study A4001029: Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation