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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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raltegravir group

The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.

Group Type EXPERIMENTAL

raltegravir

Intervention Type DRUG

400 mg two times daily for three months

No augmented treatment

Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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raltegravir

400 mg two times daily for three months

Intervention Type DRUG

Other Intervention Names

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Isentress

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No