Bone and Body Comp: A Sub Study of the SECOND-LINE Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01513122
First received: January 16, 2012
Last updated: December 1, 2013
Last verified: December 2013
Results First Received: December 1, 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: Lopinavir / ritonavir + 2-3N(t)RTI
Drug: Lopinavir /ritonavir + 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
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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
  Description
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Arm 2. Lopinavir /Ritonavir + Raltegravir Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.

Participant Flow:   Overall Study
    Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI     Arm 2. Lopinavir /Ritonavir + Raltegravir  
STARTED     102     108  
COMPLETED     91     105  
NOT COMPLETED     11     3  



  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.
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Reporting Groups
  Description
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Arm 2. Lopinavir /Ritonavir + Raltegravir Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Total Total of all reporting groups

Baseline Measures
    Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI     Arm 2. Lopinavir /Ritonavir + Raltegravir     Total  
Number of Participants  
[units: participants]
  102     108     210  
Age  
[units: years]
Mean ± Standard Deviation
  38.5  ± 7.8     38.5  ± 7.7     38.5  ± 7.8  
Gender  
[units: participants]
     
Female     47     63     110  
Male     55     45     100  



  Outcome Measures
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1.  Primary:   Mean Bone Mineral Density Changes Over 48 Weeks as Measured by DXA Scan   [ Time Frame: May 2013 ]

2.  Primary:   Mean Limbs Fat Changes Over 48 Weeks as Measured by DXA Scan   [ Time Frame: May 2013 ]

3.  Secondary:   Mean Total Body Fat Changes Over 48 Weeks as Measured by DXA Scan   [ Time Frame: May 2013 ]

4.  Secondary:   Mean Triglycerides Changes Over 48 Weeks as Measured by DXA Scan   [ Time Frame: May 2013 ]

5.  Secondary:   Mean Total Cholesterol Changes Over 48 Weeks as Measured by DXA Scan   [ Time Frame: May 2013 ]

6.  Secondary:   Mean Glucose Changes Over 48 Weeks as Measured by DXA Scan   [ Time Frame: May 2013 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Prof Sean Emery
Organization: The Kirby Institute
phone: +61293850900
e-mail: semery@kirby.unsw.edu.au


Publications of Results:

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01513122     History of Changes
Other Study ID Numbers: 2L body comp sub-study
Study First Received: January 16, 2012
Results First Received: December 1, 2013
Last Updated: December 1, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
South Africa: Medicines Control Council
India: Drugs Controller General of India