Trial Outcomes & Findings for Bone and Body Comp: A Sub Study of the SECOND-LINE Study (NCT NCT01513122)

NCT ID: NCT01513122

Last Updated: 2025-06-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 210 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2025-06-26

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	102	108
Overall Study COMPLETED	91	105
Overall Study NOT COMPLETED	11	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=102 Participants 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 n=108 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.	Total n=210 Participants Total of all reporting groups
Age, Continuous	38.6 years INTER_QUARTILE_RANGE 7.8 • n=5 Participants	38.9 years INTER_QUARTILE_RANGE 7.7 • n=7 Participants	38.8 years INTER_QUARTILE_RANGE 7.8 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	63 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	45 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: 97 participants reached week 48 in 2-3N(t)RTI arm. 107 reached week 48 in the RAL arm (1 death)

Outcome measures

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=97 Participants 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 n=107 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan	-5.2 percentage change Interval -6.7 to -3.8	-2.9 percentage change Interval -4.3 to -1.5

PRIMARY outcome

Timeframe: 48 weeks

Outcome measures

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=94 Participants 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 n=107 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan	15.7 percentage change Interval 5.3 to 25.9	21.1 percentage change Interval 11.1 to 31.1

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=94 Participants 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 n=107 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan	1.4 kg Interval 0.2 to 2.7	2.1 kg Interval 0.9 to 3.3

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=94 Participants 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 n=105 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Mean Triglycerides Changes From Baseline to 48 Weeks	0.6 mmol/L Interval 0.3 to 0.9	0.8 mmol/L Interval 0.6 to 1.0

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=94 Participants 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 n=105 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Mean Total Cholesterol Changes From Baseline to 48 Weeks	0.4 mmol/L Interval 0.1 to 0.6	0.6 mmol/L Interval 0.4 to 0.9

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Measure	Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI n=94 Participants 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 n=105 Participants Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
Mean Glucose Changes From Baseline to 48 Weeks	-0.04 mmol/L Interval -0.2 to 0.2	-0.1 mmol/L Interval -0.4 to 0.1

Adverse Events

Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2. Lopinavir /Ritonavir + Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Sean Emery

The Kirby Institute

Phone: +61293850900

Email: semery@kirby.unsw.edu.au

Results disclosure agreements

• Principal investigator is a sponsor employee 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
• Publication restrictions are in place

Restriction type: OTHER