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Clinical Trial
. 2014 Jan 1;65(1):78-81.
doi: 10.1097/QAI.0b013e3182a7a97a.

Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients

Roy M Gulick  1 , Gerd Fatkenheuer, Robert Burnside, W David Hardy, Mark R Nelson, James Goodrich, Geoffrey Mukwaya, Simon Portsmouth, Jayvant R Heera
Affiliations
Free PMC article
Clinical Trial

Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients

Roy M Gulick et al. J Acquir Immune Defic Syndr. .
Free PMC article

Abstract

Background: Maraviroc is unique among approved antiretroviral drugs in targeting the host-cell chemokine coreceptor type-5 receptor. With its novel mechanism of action, we sought to describe the 5-year safety profile of maraviroc.

Methods: Two large phase 3 studies of maraviroc enrolled HIV-infected treatment-experienced patients and followed them up for 5 or more years. Survival and selected clinical end points were identified and assessed.

Results: A total of 938 enrolled patients received maraviroc-containing regimens. Rates of death and selected clinical events (eg, hepatic failure, malignancy, and myocardial infarction) were low during follow-up.

Conclusions: Maraviroc was generally safe in treatment-experienced participants for >5 years.

Trial registration: ClinicalTrials.gov NCT00098306 NCT00098722.

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References

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