Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors

Summary

This is a pilot, proof of concept, open-label clinical trial, to assess the extend of persistent viral reservoir and the level of immune activation in patients receiving suppressive treatment with protease inhibitors. 40 Chronically HIV-1 infected subjects, receiving monotherapy with ritonavir-boosted lopinavir or darunavir for at least 12 months with plasma viremia below 50 copies HIV RNA per ml, and CD4 T-cell counts greater than 500 cells/mm3 will be included. The total duration of the study will be 48 weeks: 12 weeks for patients' inclusion, 24 weeks of follow-up once the last patient is included, and 12 weeks for data analysis.

Timeline

Start

2012-05

Primary completion

2014-05

Completion

2014-05

Publications

• Puertas MC, Gomez-Mora E, Santos JR, Molto J, Urrea V, Moron-Lopez S, Hernandez-Rodriguez A, Marfil S, Martinez-Bonet M, Matas L, Munoz-Fernandez MA, Clotet B, Blanco J, Martinez-Picado J. Impact of intensification with raltegravir on HIV-1-infected individuals receiving monotherapy with boosted PIs. J Antimicrob Chemother. 2018 Jul 1;73(7):1940-1948. doi: 10.1093/jac/dky106.

Drugs

Indications