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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: raltegravir||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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|
Experimental: raltegravir group
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
400 mg two times daily for three months
Other Name: Isentress
No Intervention: No augmented treatment
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
- 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.
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|
|Ucsf Ccrc, Sfgh|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Richard Price, MD||University of California, San Francisco|