Status:
COMPLETED
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
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, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combi...
Eligibility Criteria
Inclusion
- Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
- 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
- Subjects were excluded if screening laboratory analyses showed hemoglobin \<= 8.0 grams per deciliter.
- 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).
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00358917
Start Date
August 1 2006
End Date
November 1 2008
Last Update
April 11 2011
Active Locations (1)
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1
Medical Information - Abbott (1-800-633-9110)
Abbott Park, Illinois, United States, 60064