Pilot Study to Assess the Role of Immune Activation and Apoptosis as a Marker for Treatment Intensification With Raltegravir in Hiv-infected Patients on Antiretroviral Therapy With Long-term Viral Suppression and Unfavourable Immunologic Response (Discordant Patients: v+i-)

NCT00773708 Phase 4 COMPLETED

This study aims to provide new knowledge about the pathogenesis of HIV infection, specifically, the role that immune activation and apoptotic activity play in immune recovery, and in particular, in the paradoxical immunologic response of some patients on antiretroviral therapy despite achievement of sustained and complete viral suppression. In this regard, the investigators will prospectively evaluate the impact of intensification with Raltegravir in those "discordants" patients with high index of immune activation, measured as the percentage of CD8+HLADR+CD38+ cells. This will provide relevant information on the effectiveness of this drug in guided intensification regimens.

Details

Lead sponsor	Germans Trias i Pujol Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	57
Start date	2009-03
Completion	2011-05

Conditions

• HIV Infections

Interventions

• raltegravir

Primary outcomes

• CD4 cell count — From Basal to 48 week (last visit) every 3 months

Countries

Spain