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

Phase 3

Completed

• Conditions: Human Immunodeficiency Virus Infections
• Interventions: Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

• Registration Number: NCT00358917
• Lead Sponsor: Abbott

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study Start: 2006-08
• Study First Posted: 2006-08-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-12
• Results First Submitted QC: 2010-01-07
• Results First Posted: 2010-02-01
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)	-
LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm	Week 48 (End of Study)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48	Week 48 (End of Study)
Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts	Week 48 (End of Study)
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	Week 48 (End of Study)	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	Week 48 (End of Study)	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).

Trial Locations

Locations (1)

Medical Information - Abbott (1-800-633-9110); 🇺🇸 Abbott Park, Illinois, United States