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
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus Infections
Intervention: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) (Drug); lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Thomas J Podsadecki, MD, Study Director, Affiliation: Abbott
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 combination with nucleoside/nucleotide reverse transcriptase inhibitors
(NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects
with detectable viral load while receiving their current antiretroviral therapy.
Clinical Details
Official title: A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir (LPV/r) Tablets 800/200 Milligram (mg) Once-Daily (QD) Versus 400/100 mg Twice-Daily (BID) When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in Antiretroviral-Experienced, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
Secondary outcome: Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir Percentage of Participants With New Primary Protease Mutations at Week 48
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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).
Locations and Contacts
Medical Information - Abbott (1-800-633-9110), Abbott Park, Illinois 60064, United States
Additional Information
Starting date: August 2006
Last updated: April 7, 2011
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