A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects

NCT00262522 Phase 3 COMPLETED Results posted

The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	664
Start date	2005-11
Completion	2008-07

Conditions

• Human Immunodeficiency Virus Infections

Interventions

• lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
• lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
• lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
• lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Primary outcomes

• Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks — Week 8
• Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48 — Week 48

Countries

United States, Australia, Belgium, Canada, Czechia, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Puerto Rico, Russia, Singapore, Spain, Switzerland, Taiwan, United Kingdom