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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition: HIV Infections
Interventions: Drug: raltegravir
Drug: Study NNRTI
Drug: Study PI

  Participant Flow

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
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 



  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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Who Experienced an Increase in CD4% in the Ileum.   [ Time Frame: 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Average Change in "Activated" (CD38+HLADR+) CD8+ T Cells in the Ileum   [ Time Frame: 12 weeks ]
  Show Outcome Measure 4


  Serious Adverse Events


  Other Adverse Events


  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
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


  More Information