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Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929759
First Posted: August 28, 2013
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Gilead Sciences
Information provided by (Responsible Party):
Nina Lin, MD, Massachusetts General Hospital
Results First Submitted: March 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: HIV Disease
Intervention: Drug: Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)

  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
Drug Switching

Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.

Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks


Participant Flow:   Overall Study
    Drug Switching
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  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
Drug Switching

Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.

Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks


Baseline Measures
   Drug Switching 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  10.0% 
Male      9  90.0% 
Region of Enrollment 
[Units: Participants]
 
United States   10 
Baseline measures for Neurometabolites Based on MRS [1] 
[Units: Arbitrary units]
Mean (Standard Deviation)
 
Posterior cingulate creatine   19.09  (2.27) 
Posterior cingulate glutamate   25.36  (3.73) 
Posterior cingulate GABA   4.99  (1.29) 
Anterior cingulate creatine   14.06  (2.44) 
Anterior cingulate glutamate   19.16  (3.11) 
Anterior cingulate GABA   4.21  (1.18) 
[1] The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from baseline to the second time point.


  Outcome Measures
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1.  Primary:   Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)   [ Time Frame: week 0 to week 8 ]

2.  Primary:   Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)   [ Time Frame: week 0 and week 8 ]

3.  Secondary:   Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8   [ Time Frame: week 0 to week 8 ]

4.  Secondary:   Neurocognitive Changes   [ Time Frame: week 0 and week 8 ]

5.  Secondary:   Fasting Lipid Profile   [ Time Frame: 8 weeks ]

6.  Secondary:   Sleep Quality   [ Time Frame: week 0 and week 8 ]

7.  Secondary:   ART Regimen Preference   [ Time Frame: week 0 and week 8 ]

8.  Secondary:   Markers of Immune Activation   [ Time Frame: week 0 and week 8 ]

9.  Secondary:   Effect of EFV and Its Metabolites   [ Time Frame: week 0 and week 8 ]


  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
One participant did not have repeat fMRI because the pre-switch fMRI was not done correctly. The patient did not fully understand the tasks to be performed, therefore no repeat follow up fMRI was done without the comparator study.


  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: Dr. Nina Lin
Organization: Boston Medical Center, Boston University School of Medicine
phone: 617-414-5242
e-mail: nina.lin@bmc.org



Responsible Party: Nina Lin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01929759     History of Changes
Other Study ID Numbers: NeuroHIV001
First Submitted: August 23, 2013
First Posted: August 28, 2013
Results First Submitted: March 27, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017