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

NCT00358917 | Completed Phase 3 Results DMC

• 1 other identifier: M06-802
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus Infections

Outcome Measures

Primary Outcomes (1)

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

  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.

  Week 48 (End of Study)

Secondary Outcomes (4)

• 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)

• Percentage of Participants With New Primary Protease Mutations at Week 48

  Week 48 (End of Study)

Study Arms (2)

LPV/r 800/200 mg QD Tablet

EXPERIMENTAL

Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

LPV/r 400/100 mg BID Tablet

ACTIVE COMPARATOR

Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

Interventions

lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) DRUG

LPV/r 800/200 mg once-daily (QD) tablet

Also known as: ABT-378, lopinavir/ritonavir, Kaletra

LPV/r 800/200 mg QD Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Medical Information - Abbott (1-800-633-9110)

Abbott Park, Illinois, 60064, United States

Location

MeSH Terms

Interventions

Lopinavir; Ritonavir; Tablets; lopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

800-633-9110

Study Officials

• Thomas J Podsadecki, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 11, 2011
• Results First Posted: February 1, 2010

Record last verified: 2011-04

Locations

US (1)