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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
History of Changes
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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  



  Baseline Characteristics
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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.

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 ]
  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 ]
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Measure Type Secondary
Measure Title Number of Subjects Who Experienced an Increase in CD4% in the Ileum.
Measure Description 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
Time Frame 12 weeks  
Safety Issue No  

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.
Includes all those who had endoscopy at week 12

Reporting Groups
  Description
Intensification Arm 5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir

Measured Values
    Intensification Arm  
Number of Participants Analyzed  
[units: participants]
 		  7  
Number of Subjects Who Experienced an Increase in CD4% in the Ileum.  
[units: participants]
 		  5  

No statistical analysis provided for Number of Subjects Who Experienced an Increase in CD4% in the Ileum.



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
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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  


Results Point of Contact:  
Name/Title: Steven Yukl
Organization: UCSF
phone: 415-221-4810 ext 3930
e-mail: steven.yukl@ucsf.edu


Publications of Results:


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00884793     History of Changes
Other Study ID Numbers: PLUS1
Study First Received: April 20, 2009
Results First Received: August 8, 2011
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board