Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen

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. Identifier: NCT01978743
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nina Lin, MD, Boston University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: HIV
HIV-associated Neurocognitive Disorder
Intervention: Drug: Raltegravir

  Participant Flow

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

All participants are switched from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + truvada (FTC/TDF).

Raltegravir will be administered 400mg twice-a-day.

Participant Flow:   Overall Study

  Baseline Characteristics

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.
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Reporting Groups
Raltegravir All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      10 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  40.0% 
Male      6  60.0% 
Region of Enrollment 
[Units: Participants]
United States   10 

  Outcome Measures

1.  Primary:   Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)   [ Time Frame: week 0 and week 8 ]

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

3.  Secondary:   Other Neurometabolite Changes Measured by MRS   [ Time Frame: week 0 and week 8 ]

4.  Secondary:   Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI   [ Time Frame: week 0 and week 8 ]

5.  Secondary:   Fasting Lipid Profile   [ Time Frame: week 0 and week 8 ]

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:   Change in Level of EFV and Metabolites   [ Time Frame: week 0 and week 8 ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

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 University School of Medicine
phone: 617-414-5242

Responsible Party: Nina Lin, MD, Boston University Identifier: NCT01978743     History of Changes
Other Study ID Numbers: NeuroHIV002
First Submitted: October 20, 2013
First Posted: November 7, 2013
Results First Submitted: June 8, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017