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
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Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
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Study Type: | Interventional |
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Study Design: | Intervention Model: Single Group Assignment; Masking: None (Open Label) |
Condition: |
HIV Infections |
Interventions: |
Drug: raltegravir Drug: Study NNRTI Drug: Study PI |

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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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Reporting Groups
Description | |
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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 | |
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STARTED | 8 |
COMPLETED | 7 |
NOT COMPLETED | 1 |
Withdrawal by Subject | 1 |

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 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 |