Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut (PLUS)
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00884793
First received: April 20, 2009
Last updated: June 18, 2012
Last verified: June 2012
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Results First Received: August 8, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Intervention Model: Single Group Assignment; Masking: Open Label |
| Condition: |
HIV Infections |
| Interventions: |
Drug: raltegravir Drug: Study NNRTI Drug: Study PI |
Participant Flow
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Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Intensification Arm | In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. 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), while 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. |
Participant Flow: Overall Study
| Intensification Arm | |
|---|---|
| STARTED | 8 |
| COMPLETED | 7 |
| NOT COMPLETED | 1 |
| Withdrawal by Subject | 1 |
Show Baseline Characteristics
Outcome Measures
| 1. Primary: | Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum [ Time Frame: 12 weeks ] |
| 2. Secondary: | Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum. [ Time Frame: 12 weeks ] |
| 3. Secondary: | Number of Subjects Who Experienced an Increase in CD4% in the Ileum. [ Time Frame: 12 weeks ] |
| 4. Secondary: | Average Change in "Activated" (CD38+HLADR+) CD8+ T Cells in the Ileum [ Time Frame: 12 weeks ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| 1) relatively small number of participants; 2) intensification may have been too short; 3)the biopsies themselves can cause inflammation/microbial leakage; 4) sampling may miss viral replication if it occurs in temporally and spatially-discrete foci |