drugset / Trial / NCT01896921

Switch to Maraviroc + Integrase Inhibitor

NCT01896921

Phase 3 Completed 7 enrolled University of Maryland, Baltimore
NaSingle-groupOpen-labelTreatment

Summary

This clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced patients to document the efficacy, safety, and tolerability of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART regimen which lessens the risk of metabolic complications could improve long-term adherence and reduce the risk of certain co-morbidities associated with long-term ART use. If this new combination is found to be as efficacious as the standard regimen with enhanced tolerability and improved metabolic effects, there is great potential for altering the current practice of HIV medicine.

Timeline

Start
2013-09
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg
Subject Maraviroc Other / unclassified 300 mg
Subject Raltegravir Other / unclassified 400 mg