Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

Phase 3

Completed

• Conditions: Human Immunodeficiency Virus Infections
• Interventions: Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

• Registration Number: NCT00262522
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-05
• Study First Submitted QC: 2005-12-05
• Study First Posted: 2005-12-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-09
• Results First Submitted QC: 2009-08-19
• Results First Posted: 2009-08-20
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)	-
LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)	-
LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)	-
LPV/r 400/100 mg BID SGC (Through Week 8)	lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96	Week 96 (End of Study)
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts	Week 96 (End of Study)

Trial Locations

Locations (129)

Site Reference ID/Investigator# 823; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 846; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 851; 🇺🇸 Beverly Hills, California, United States

Site Reference ID/Investigator# 872; 🇺🇸 Fountain Valley, California, United States

Site Reference ID/Investigator# 826; 🇺🇸 Long Beach, California, United States

Site Reference ID/Investigator# 876; 🇺🇸 Newport Beach, California, United States

Site Reference ID/Investigator# 875; 🇺🇸 Washington, District of Columbia, United States

Site Reference ID/Investigator# 870; 🇺🇸 Atlantis, Florida, United States

Site Reference ID/Investigator# 844; 🇺🇸 Fort Lauderdale, Florida, United States

Site Reference ID/Investigator# 874; 🇺🇸 Miami, Florida, United States

Scroll for more (119 remaining)