Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients
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ClinicalTrials.gov Identifier: NCT00672932 |
Recruitment Status
:
Completed
First Posted
: May 6, 2008
Results First Posted
: July 5, 2013
Last Update Posted
: July 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: raltegravir | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Pilot Study of Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: raltegravir group
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
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Drug: raltegravir
400 mg two times daily for three months
Other Name: Isentress
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No Intervention: No augmented treatment
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
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- Change in CSF Concentrations of Neopterin After 12 Weeks [ Time Frame: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period) ]CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.
- Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR [ Time Frame: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period) ]Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672932
United States, California | |
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San Francisco, California, United States, 94110 |
Principal Investigator: | Richard Price, MD | University of California, San Francisco |
Publications of Results:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00672932 History of Changes |
Other Study ID Numbers: |
CCRC5004 R01MH062701 ( U.S. NIH Grant/Contract ) |
First Posted: | May 6, 2008 Key Record Dates |
Results First Posted: | July 5, 2013 |
Last Update Posted: | July 5, 2013 |
Last Verified: | May 2013 |
Keywords provided by University of California, San Francisco:
raltegravir central nervous system (CNS) HIV-1 AIDS |
cerebrospinal fluid (CSF) immunoactivation antiretroviral therapy suppression |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |