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Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients

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ClinicalTrials.gov Identifier: NCT00672932
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : July 5, 2013
Last Update Posted : July 5, 2013
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition HIV Infections
Intervention Drug: raltegravir
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raltegravir Group No Augmented Treatment Then Optional Rollover
Hide Arm/Group Description The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol. Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
Period Title: Overall Study
Started 9 9
Completed Initial 12-week Assignment 9 9
Provided Analyzable Blood and CSF Sample 8 [1] 9
Rolled Over to Raltegravir 0 6 [2]
Completed 9 9
Not Completed 0 0
[1]
one subject was censored when pharmacological study showed no drug in plasma or CSF
[2]
6 subjects randomized to no drug later rolled over to receive raltegravir
Arm/Group Title Raltegravir Group No Augmented Treatment Total
Hide Arm/Group Description The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol. Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
52.7  (6.4) 54.3  (5.3) 53.9  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
0
   0.0%
1
  11.1%
1
   5.6%
Male
9
 100.0%
8
  88.9%
17
  94.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9 9 18
1.Primary Outcome
Title Change in CSF Concentrations of Neopterin After 12 Weeks
Hide Description CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.
Time Frame three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.
Arm/Group Title Raltegravir Group No Augmented Treatment
Hide Arm/Group Description:
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
Overall Number of Participants Analyzed 14 9
Mean (Standard Deviation)
Unit of Measure: nmol/L
0.1  (0.3) 0.3  (1.1)
2.Secondary Outcome
Title Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR
Hide Description Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.
Time Frame three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.
Arm/Group Title Raltegravir Group No Augmented Treatment
Hide Arm/Group Description:
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
Overall Number of Participants Analyzed 14 9
Mean (Standard Deviation)
Unit of Measure: percentage of cells
0.51  (1.03) 0.66  (1.20)
Time Frame 12 weeks
Adverse Event Reporting Description 6 subjects who rolled over to treatment after 12 weeks of no treatment were followed for an additional 12 weeks. 1 subject in the Raltegravir group was not included in other analyses because a pharmacological study showed no drug in either plasma or CSF.
 
Arm/Group Title Raltegravir Group No Augmented Treatment
Hide Arm/Group Description The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol. Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
All-Cause Mortality
Raltegravir Group No Augmented Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir Group No Augmented Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir Group No Augmented Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/9 (0.00%) 
The underlying hypothesis might not have actually been addressed because of the particular makeup of the subject group with minimal CNS infection and immunoactivation that left little room to discern a therapeutic effect.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Richard W. Price, M.D.
Organization: UCSF
Phone: 415-206-4487
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00672932     History of Changes
Other Study ID Numbers: CCRC5004
R01MH062701 ( U.S. NIH Grant/Contract )
First Submitted: April 29, 2008
First Posted: May 6, 2008
Results First Submitted: June 18, 2012
Results First Posted: July 5, 2013
Last Update Posted: July 5, 2013