IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maraviroc | Other / unclassified | 150 mg | Oral |
| Subject | Maraviroc | Other / unclassified | 300 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |