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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00358917
First received: July 28, 2006
Last updated: April 7, 2011
Last verified: April 2011

July 28, 2006
April 7, 2011
August 2006
November 2008   (final data collection date for primary outcome measure)
Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.
  • The frequency and percentage of treatment-emergent adverse events
  • The frequency and percentage of very low and very high laboratory values will be compared between treatment groups
  • The change from baseline to each visit for laboratory values will be summarized by treatment group
  • The proportion of subjects responding (i.e., not demonstrating virologic failure) at Week 48 based on the FDA Time to Loss of Virologic Response Algorithm
Complete list of historical versions of study NCT00358917 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48 [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
    Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.
  • Percentage of Participants With New Primary Protease Mutations at Week 48 [ Time Frame: Week 48 (End of Study) ] [ Designated as safety issue: No ]
    Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).
  • The proportion of subjects responding (i.e., not demonstrating virologic failure) at each visit based on the FDA Time to Loss of Virologic Response Algorithm
  • The relationship between baseline genotypic resistance and virologic response
  • The frequency and percentage of the emergence of mutations at virologic rebound that were not present at baseline
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus Infections
  • Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
    LPV/r 800/200 mg once-daily (QD) tablet
    Other Names:
    • ABT-378
    • lopinavir/ritonavir
    • Kaletra
  • Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
    LPV/r 400/100 mg twice-daily (BID) tablet
    Other Names:
    • ABT-378
    • lopinavir/ritonavir
    • Kaletra
  • Experimental: LPV/r 800/200 mg QD Tablet
    Intervention: Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
  • Active Comparator: LPV/r 400/100 mg BID Tablet
    Intervention: Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
599
November 2008
November 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00358917
M06-802
Yes
Barry Bernstein, MD, Project Director, Abbott
Abbott
Not Provided
Study Director: Thomas J Podsadecki, MD Abbott
Abbott
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP