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Bone and Body Comp Substudy of SECOND-LINE
NCT01513122Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2010
- Primary completion
- Sep 2012
- Countries
- 5
- Sponsor
- The Kirby Institute
- Modality
- Small Molecules
- Drugs
- raltegravir
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 4, randomised, open-label trial of raltegravir in human immunodeficiency virus infection (HIV) (2 arms), sponsored by The Kirby Institute. Primary endpoints: Mean Bone Mineral Density Changes From Baseline to 48 Weeks at Proximal Femur and Mean Limbs Fat Changes From Baseline to 48 Weeks. Started Feb 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Control Arm
Lopinavir/ritonavir + 2-3 N(t)RTIs
Experimental Arm
Lopinavir/ritonavir + Raltegravir
03
Who it enrols
HIV-1 positive patients aged 16+ who failed first-line NNRTI + 2N(t)RTI therapy (VL > 500 copies/mL). No prior PI or Integrase Inhibitor exposure.
04
Endpoints
Primary
Mean Bone Mineral Density Changes From Baseline to 48 Weeks at Proximal Femur
Mean Limbs Fat Changes From Baseline to 48 Weeks
Secondary
Mean Total Body Fat Changes From Baseline to 48 Weeks
Mean Triglycerides Changes From Baseline to 48 Weeks
Mean Total Cholesterol Changes From Baseline to 48 Weeks
Mean Glucose Changes From Baseline to 48 Weeks
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