Phase 3
Completed N=664
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
Human Immunodeficiency Virus Infections
Source: ClinicalTrials.gov NCT00262522 ↗
Enrolled (actual)
664
Serious AEs
13.1%
Results posted
Aug 2009
Primary outcomePrimary: Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks — 49.1; 54.8; 44.6; 49.7 Percentage of Subjects — p=>0.100
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks |
49.1; 54.8; 44.6; 49.7 | >0.100 |
| PRIMARY Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48 |
77.2; 75.8 | 0.715 |
| SECONDARY Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96 |
64.9; 69.2 | 0.249 |
| SECONDARY Mean Change From Baseline to Week 96 in CD4+ T Cell Counts |
238.4; 254.0 | 0.269 |
Eligibility Criteria
Inclusion Criteria
- Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with = 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 = 3.0 x Upper Limit of Normal (ULN)
- Calculated creatinine clearance < 50 mL/min
Data sourced from ClinicalTrials.gov (NCT00262522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.