Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut (PLUS)

This study has been completed.
Sponsor:
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
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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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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Baseline Measures
    Intensification Arm  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.9  ± 11.5  
Gender  
[units: participants]
 
Female     0  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
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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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


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