Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00672932

Run by

University of California, San Francisco

People needed

18

Starts

2008-04-01

Expected to finish

2011-02-01

Last updated by the study team

2013-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capacity to provide informed consent.
• Documented HIV-1 infection.
• History of continuous cART treatment (with at least three drugs) for at least 2 years.
• Documentation of 'undetectable' plasma HIV-1 RNA for at least 1 year.
• HIV-1 RNA <50 copies/mL in plasma and CSF at screening visit.

You may not qualify if…

• Contraindication to LP (suspicion of CNS mass lesion, bleeding diathesis, etc.).
• Prior experience with raltegravir or contraindication to raltegravir treatment, including medication interactions that might compromise ongoing antiretroviral therapy or treatment of other conditions.
• Active opportunistic infections or neurological diseases.
• Other conditions or treatments likely to interfere with treatment or evaluation.
• Hemoglobin < 10 Gm/dL.
• Pregnant or anticipating pregnancy during study.
• Active substance abuse.
• Subjects taking rifampin, phenytoin, Phenobarbital or other drugs that accelerate raltegravir metabolism and might decrease its tissue concentrations.

Where it is running

• Ucsf Ccrc, Sfgh — San Francisco, California, United States

Full record on ClinicalTrials.gov

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