Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00262522
First received: December 5, 2005
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.


Condition Intervention Phase
Human Immunodeficiency Virus Infections
Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96 [ Time Frame: Week 96 (End of Study) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 96 in CD4+ T Cell Counts [ Time Frame: Week 96 (End of Study) ] [ Designated as safety issue: No ]

Enrollment: 664
Study Start Date: November 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LPV/r 800/200 mg QD Tablet Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD
Other Name: ABT-378, Kaletra, lopinavir/ritonavir
Experimental: LPV/r 800/200 mg QD SGC (Through Week 8) Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD
Other Name: ABT-378, Kaletra, lopinavir/ritonavir
Active Comparator: LPV/r 400/100 mg BID Tablet Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD
Other Name: ABT-378, Kaletra, lopinavir/ritonavir
Active Comparator: LPV/r 400/100 mg BID SGC (Through Week 8) Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD
Other Name: ABT-378, Kaletra, lopinavir/ritonavir

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with < 7 days of prior antiretroviral therapy.
  • Subjects had plasma HIV-1 ribonucleic acid (RNA) levels >= 1,000 copies/mL at screening and were not acutely ill.
  • Female subjects were nonpregnant and nonlactating.

Exclusion Criteria

  • Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results:

    • Presence of hepatitis B surface antigen (HBsAg)
    • Hemoglobin <= 8.0 g/dL
    • Absolute neutrophil count <= 750 cells/microliter
    • Platelet count <= 50,000 per mL
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3.0 x Upper Limit of Normal (ULN)
    • Calculated creatinine clearance < 50 mL/min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262522

  Show 129 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Daniel E Cohen, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00262522     History of Changes
Other Study ID Numbers: M05-730, 2005-001430-32
Study First Received: December 5, 2005
Results First Received: July 9, 2009
Last Updated: February 3, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Abbott:
Human Immunodeficiency Virus Infections

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Infection
HIV Infections
Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014