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Trial record 17 of 21 for:    " December 28, 2011":" January 27, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01513122
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : January 17, 2014
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: Lopinavir / ritonavir + 2-3N(t)RTI
Drug: Lopinavir /ritonavir + raltegravir
Enrollment 211
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Period Title: Overall Study
Started 102 108
Completed 91 105
Not Completed 11 3
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir Total
Hide Arm/Group Description Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily. Total of all reporting groups
Overall Number of Baseline Participants 102 108 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 108 participants 210 participants
38.5  (7.8) 38.5  (7.7) 38.5  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 108 participants 210 participants
Female
47
  46.1%
63
  58.3%
110
  52.4%
Male
55
  53.9%
45
  41.7%
100
  47.6%
1.Primary Outcome
Title Mean Bone Mineral Density Changes Over 48 Weeks as Measured by DXA Scan
Hide Description [Not Specified]
Time Frame May 2013
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description:
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Overall Number of Participants Analyzed 97 107
Mean (95% Confidence Interval)
Unit of Measure: percentage of BMD change
-5.2
(-6.7 to -3.8)
-2.9
(-4.3 to -1.5)
2.Primary Outcome
Title Mean Limbs Fat Changes Over 48 Weeks as Measured by DXA Scan
Hide Description [Not Specified]
Time Frame May 2013
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description:
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Overall Number of Participants Analyzed 94 107
Mean (95% Confidence Interval)
Unit of Measure: percentage of limb fat change
15.7
(5.3 to 25.9)
21.1
(11.1 to 31.1)
3.Secondary Outcome
Title Mean Total Body Fat Changes Over 48 Weeks as Measured by DXA Scan
Hide Description [Not Specified]
Time Frame May 2013
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description:
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Overall Number of Participants Analyzed 94 107
Mean (95% Confidence Interval)
Unit of Measure: kg
1.4
(0.2 to 2.7)
2.1
(0.9 to 3.3)
4.Secondary Outcome
Title Mean Triglycerides Changes Over 48 Weeks as Measured by DXA Scan
Hide Description [Not Specified]
Time Frame May 2013
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description:
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Overall Number of Participants Analyzed 94 105
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
0.6
(0.3 to 0.9)
0.8
(0.6 to 1.0)
5.Secondary Outcome
Title Mean Total Cholesterol Changes Over 48 Weeks as Measured by DXA Scan
Hide Description [Not Specified]
Time Frame May 2013
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description:
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Overall Number of Participants Analyzed 94 105
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
0.4
(0.1 to 0.6)
0.6
(0.4 to 0.9)
6.Secondary Outcome
Title Mean Glucose Changes Over 48 Weeks as Measured by DXA Scan
Hide Description [Not Specified]
Time Frame May 2013
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description:
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Overall Number of Participants Analyzed 94 105
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
-0.04
(-0.2 to 0.2)
-0.1
(-0.4 to 0.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were not planned to be analyzed for the sub-study and that complete adverse event information is included in the main study report (NCT00931463)
 
Arm/Group Title Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Hide Arm/Group Description Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
All-Cause Mortality
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI Arm 2. Lopinavir /Ritonavir + Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.

There is a Clinical Trial Agreement signed with each PI detailing the publication policy and disclosure of study's information, in summary:

The Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the sponsor, except for the purposes of internal training Publications or presentations of results from the Study will follow the agreement's publication/presentation guidelines

Results Point of Contact
Name/Title: Prof Sean Emery
Organization: The Kirby Institute
Phone: +61293850900
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01513122     History of Changes
Other Study ID Numbers: 2L body comp sub-study
First Submitted: January 16, 2012
First Posted: January 20, 2012
Results First Submitted: December 1, 2013
Results First Posted: January 17, 2014
Last Update Posted: January 17, 2014