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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nina Lin, MD, Boston University
ClinicalTrials.gov Identifier:
NCT01978743
First received: October 20, 2013
Last updated: July 18, 2017
Last verified: July 2017
Results First Received: June 8, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: HIV
HIV-associated Neurocognitive Disorder
Neurotoxicity
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

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

Baseline Measures
   Raltegravir 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[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
  Show All 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
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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
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  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 University School of Medicine
phone: 617-414-5242
e-mail: nina.lin@bmc.org



Responsible Party: Nina Lin, MD, Boston University
ClinicalTrials.gov Identifier: NCT01978743     History of Changes
Other Study ID Numbers: NeuroHIV002
Study First Received: October 20, 2013
Results First Received: June 8, 2017
Last Updated: July 18, 2017