Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut (PLUS)
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|ClinicalTrials.gov Identifier: NCT00884793|
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : July 23, 2012
Last Update Posted : July 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: raltegravir Drug: Study NNRTI Drug: Study PI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Longitudinal Pilot Study to Measure the Effect of Intensification With Raltegravir +/- a Protease Inhibitor (PI) or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) on HIV-1 Levels in the Gut|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
Experimental: intensification with raltegravir +/- NNRTI or PI
Intensification with raltegravir 400mg PO BID +/- a study PI or NNRTI
The baseline ART regimen will be intensified with raltegravir 400mg orally (PO) twice daily (BID) (all participants) +/- a study NNRTI or protease inhibitor (PI) (at the option of the participant and the study clinical team).
Other Name: Isentress
Drug: Study NNRTI
Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine).
Drug: Study PI
Subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
- Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum [ Time Frame: 12 weeks ]Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum
- Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum. [ Time Frame: 12 weeks ]Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12.
- Number of Subjects Who Experienced an Increase in CD4% in the Ileum. [ Time Frame: 12 weeks ]Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum
- Average Change in "Activated" (CD38+HLADR+) CD8+ T Cells in the Ileum [ Time Frame: 12 weeks ]Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry
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): NCT00884793
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|San Francisco VA Medical Center (SFVAMC)|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Diane Havlir, MD||San Francisco General Hospital (SFGH) and University of California San Francisco (UCSF)|
|Principal Investigator:||Joseph K Wong, MD||San Francisco VA Medical Center (SFVAMC) and University of California, San Francisco (UCSF)|
|Principal Investigator:||Steven Yukl, MD||SFVMAC and UCSF|