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

Abbott

Status and phase

Completed

Phase 3

Conditions

Human Immunodeficiency Virus Infections

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00262522

2005-001430-32 (EudraCT Number)

M05-730

Details and patient eligibility

About

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.

Enrollment

664 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

664 participants in 4 patient groups

LPV/r 800/200 mg QD Tablet

Experimental group

Treatment:

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

LPV/r 800/200 mg QD SGC (Through Week 8)

Experimental group

Treatment:

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

LPV/r 400/100 mg BID Tablet

Active Comparator group

Treatment:

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

LPV/r 400/100 mg BID SGC (Through Week 8)

Active Comparator group

Treatment:

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

Trial contacts and locations

129

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