Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Samir Gupta, Indiana University
ClinicalTrials.gov Identifier:
NCT01270802
First received: January 4, 2011
Last updated: November 24, 2013
Last verified: November 2013
Results First Received: August 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Tenofovir/emtricitabine
Drug: Tenofovir/emtricitabine/efavirenz
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
Enrollment into this trial occurred between April 2011 and May 2012. Participants were recruited from the HIV outpatient clinics associated with the Indiana University Health medical system.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-two persons screened for enrollment. Two of these failed screening (both for having screening HIV-1 RNA levels >50 copies/mL); the remaining 30 were equally randomized into the two study groups.

Reporting Groups
  Description
Continued Tenofovir/Emtricitabine/Efavirenz Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
Switch to Tenofovir/Emtricitabine Plus Raltegravir Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily

Participant Flow:   Overall Study
    Continued Tenofovir/Emtricitabine/Efavirenz     Switch to Tenofovir/Emtricitabine Plus Raltegravir  
STARTED     15     15  
COMPLETED     13     14  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 0  
Adverse Event                 1                 0  
Lost to Follow-up                 0                 1  



  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
Continued Tenofovir/Emtricitabine/Efavirenz Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
Switch to Tenofovir/Emtricitabine/Raltegravir

Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir

Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine

Total Total of all reporting groups

Baseline Measures
    Continued Tenofovir/Emtricitabine/Efavirenz     Switch to Tenofovir/Emtricitabine/Raltegravir     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 12     39  ± 10.6     39  ± 11  
Gender  
[units: participants]
     
Female     2     1     3  
Male     13     14     27  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Change in Flow-mediated Dilation (FMD) of the Brachial Artery   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Change in Serum Levels of Vitamin D   [ Time Frame: Baseline and 24 weeks ]


  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 study was open-label. Correction for multiple testing was not performed, so apparently significant results may be falsely positive.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Samir K. Gupta, Principal Investigator
Organization: Indiana University School of Medicine
phone: 317-274-7926
e-mail: sgupta1@iu.edu


No publications provided


Responsible Party: Samir Gupta, Indiana University
ClinicalTrials.gov Identifier: NCT01270802     History of Changes
Other Study ID Numbers: Merck 38258
Study First Received: January 4, 2011
Results First Received: August 14, 2013
Last Updated: November 24, 2013
Health Authority: United States: Institutional Review Board