Status:
COMPLETED
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
Lead Sponsor:
Abbott
Conditions:
Human Immunodeficiency Virus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 co...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT00262522
Start Date
November 1 2005
End Date
July 1 2008
Last Update
February 6 2012
Active Locations (129)
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1
Site Reference ID/Investigator# 823
Phoenix, Arizona, United States, 85006
2
Site Reference ID/Investigator# 846
Phoenix, Arizona, United States, 85012
3
Site Reference ID/Investigator# 851
Beverly Hills, California, United States, 90211
4
Site Reference ID/Investigator# 872
Fountain Valley, California, United States, 92708