Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
NCT ID: NCT00358917
Last Updated: 2011-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
599 participants
INTERVENTIONAL
2006-08-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LPV/r 800/200 mg QD Tablet
lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg once-daily (QD) tablet
LPV/r 400/100 mg BID Tablet
lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg twice-daily (BID) tablet
Interventions
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lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg once-daily (QD) tablet
lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg twice-daily (BID) tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects had plasma HIV-1 ribonucleic acid (RNA) levels \> 1,000 copies/mL at screening and were not acutely ill.
* Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels \> 400 copies/mL with the most recent being \> 1000 copies/mL, and in the investigator's opinion, should change therapy
* Female subjects were nonpregnant and nonlactating.
Exclusion Criteria
* Subjects were excluded if screening laboratory analyses showed absolute neutrophil count \<= 750 cells/microliter.
* Subjects were excluded if screening laboratory analyses showed platelet count \<= 50,000 per cubic millimeter.
* Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 5.0 x upper limit of normal (ULN).
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Thomas J Podsadecki, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Medical Information - Abbott (1-800-633-9110)
Abbott Park, Illinois, United States
Countries
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Other Identifiers
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M06-802
Identifier Type: -
Identifier Source: org_study_id
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