drugset / Trial / NCT00935480

IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients

NCT00935480

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r). To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by: * residual plasma replication between 0 and 50 copies/ml * intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL). * proviral HIV DNA levels in PBMC and RL.

Timeline

Start
2010-10
Primary completion
2010-11-12
Completion
2014-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Maraviroc Other / unclassified 150 mg Oral
Subject Maraviroc Other / unclassified 300 mg Oral
Subject Raltegravir Other / unclassified 400 mg Oral