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

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: NCT01270802
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : October 24, 2013
Last Update Posted : December 18, 2013
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Samir Gupta, Indiana University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Tenofovir/emtricitabine
Drug: Tenofovir/emtricitabine/efavirenz
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
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
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 
Withdrawal by Subject                1                0 
Adverse Event                1                0 
Lost to Follow-up                0                1 

  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.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   15   15   30 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 38  (12)   39  (10.6)   39  (11) 
[Units: Participants]
Female   2   1   3 
Male   13   14   27 
Region of Enrollment 
[Units: Participants]
United States   15   15   30 

  Outcome Measures

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

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

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

Responsible Party: Samir Gupta, Indiana University Identifier: NCT01270802     History of Changes
Other Study ID Numbers: Merck 38258
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: August 14, 2013
Results First Posted: October 24, 2013
Last Update Posted: December 18, 2013