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

Completed · Phase 3

Conditions studied: Human Immunodeficiency Virus Infections

In brief

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.

Key facts

Study ID

NCT00262522

Run by

Abbott

People needed

664

Starts

2005-11-01

Expected to finish

2008-07-01

Last updated by the study team

2012-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with < 7 days of prior antiretroviral therapy.
• Subjects had plasma HIV-1 ribonucleic acid (RNA) levels >= 1,000 copies/mL at screening and were not acutely ill.
• Female subjects were nonpregnant and nonlactating.

You may not qualify if…

• Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results:
• Presence of hepatitis B surface antigen (HBsAg)
• Hemoglobin <= 8.0 g/dL
• Absolute neutrophil count <= 750 cells/microliter
• Platelet count <= 50,000 per mL
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3.0 x Upper Limit of Normal (ULN)
• Calculated creatinine clearance < 50 mL/min

Where it is running

• 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 D.C., 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
• Site Reference ID/Investigator# 1153 — Orlando, Florida, United States
• Site Reference ID/Investigator# 827 — Orlando, Florida, United States
• Site Reference ID/Investigator# 783 — Plantation, Florida, United States
• Site Reference ID/Investigator# 877 — Port Saint Lucie, Florida, United States
• Site Reference ID/Investigator# 845 — Safety Harbor, Florida, United States
• Site Reference ID/Investigator# 849 — Sarasota, Florida, United States
• Site Reference ID/Investigator# 825 — Tampa, Florida, United States
• Site Reference ID/Investigator# 848 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 873 — Macon, Georgia, United States
• Site Reference ID/Investigator# 1154 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 824 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 792 — Wichita, Kansas, United States
• Site Reference ID/Investigator# 1157 — Minneapolis, Minnesota, United States
• Site Reference ID/Investigator# 871 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 2450 — Rochester, New York, United States
• Site Reference ID/Investigator# 823 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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