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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00672932
First received: April 29, 2008
Last updated: May 29, 2013
Last verified: May 2013
Results First Received: June 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: HIV Infections
Intervention: Drug: raltegravir

  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
Raltegravir Group The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
No Augmented Treatment Then Optional Rollover 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.

Participant Flow:   Overall Study
    Raltegravir Group     No Augmented Treatment Then Optional Rollover  
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



  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
Raltegravir Group The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
No Augmented Treatment Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
Total Total of all reporting groups

Baseline Measures
    Raltegravir Group     No Augmented Treatment     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52.7  ± 6.4     54.3  ± 5.3     53.9  ± 6.1  
Gender  
[units: participants]
     
Female     0     1     1  
Male     9     8     17  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  



  Outcome Measures
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1.  Primary:   Change in CSF Concentrations of Neopterin After 12 Weeks   [ Time Frame: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period) ]

2.  Secondary:   Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR   [ Time Frame: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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.


  More Information
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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
e-mail: rwprice@sfgh.ucsf.edu


Publications of Results:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00672932     History of Changes
Other Study ID Numbers: CCRC5004, R01 MH 62701
Study First Received: April 29, 2008
Results First Received: June 18, 2012
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board