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
Condition: Human Immunodeficiency Virus Infections
MeSH terms: Virus Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs); lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs); lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs); lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Intervention description: LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD; 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; LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD; 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
Intervention MeSH terms: Ritonavir; Lopinavir; Reverse Transcriptase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 664.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Immunodeficiency Virus Infections

Summary:

      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.
    

Eligibility 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