Conditions: HIV Infections
Keywords: raltegravir central nervous system (CNS) HIV-1 AIDS cerebrospinal fluid (CSF) immunoactivation antiretroviral therapy suppression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: no

Brief summary:
This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. A leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation. Based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized CNS HIV-1 replication will reduce continued CNS immunoactivation.

Detailed description:

Arms:
arm 1: The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol. arm 2: Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.

Interventions: intervention 1: raltegravir
Intervention descriptions: intervention 1: 400 mg two times daily for three months

Protocol document: