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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus Infections

Intervention / Treatment
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* Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
* Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
* Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
* Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LPV/r 800/200 mg QD Tablet<br> | Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)<br>* LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD<br>* Other names: ABT-378, Kaletra, lopinavir/ritonavir;|
| Experimental: LPV/r 800/200 mg QD SGC (Through Week 8)<br> | Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)<br>* 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<br>* Other names: ABT-378, Kaletra, lopinavir/ritonavir;|
| Active Comparator: LPV/r 400/100 mg BID Tablet<br> | Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)<br>* LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD<br>* Other names: ABT-378, Kaletra, lopinavir/ritonavir;|
| Active Comparator: LPV/r 400/100 mg BID SGC (Through Week 8)<br> | Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)<br>* 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<br>* Other names: ABT-378, Kaletra, lopinavir/ritonavir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks |  | Week 8 | 
| Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48 |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96 |  | Week 96 (End of Study) | 
| Mean Change From Baseline to Week 96 in CD4+ T Cell Counts |  | Week 96 (End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus Infections