Clinical trial NCT00358917: Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
Official title: A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir (LPV/r) Tablets 800/200 Milligram (mg) Once-Daily (QD) Versus 400/100 mg Twice-Daily (BID) When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in Antiretroviral-Experienced, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus Infections
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.


Eligibility criteria: Inclusion Criteria:

* Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
* Subjects had plasma HIV-1 ribonucleic acid (RNA) levels \> 1,000 copies/mL at screening and were not acutely ill.
* Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels \> 400 copies/mL with the most recent being \> 1000 copies/mL, and in the investigator's opinion, should change therapy
* Female subjects were nonpregnant and nonlactating.

Exclusion Criteria:

* Subjects were excluded if screening laboratory analyses showed hemoglobin \<= 8.0 grams per deciliter.
* Subjects were excluded if screening laboratory analyses showed absolute neutrophil count \<= 750 cells/microliter.
* Subjects were excluded if screening laboratory analyses showed platelet count \<= 50,000 per cubic millimeter.
* Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 5.0 x upper limit of normal (ULN).

Primary outcomes:
measure: Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
timeFrame: Week 48 (End of Study)
Secondary outcomes:
measure: Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48
timeFrame: Week 48 (End of Study)
measure: Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts
timeFrame: Week 48 (End of Study)
measure: Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir
timeFrame: Week 48 (End of Study)
measure: Percentage of Participants With New Primary Protease Mutations at Week 48
timeFrame: Week 48 (End of Study)
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Medical Information - Abbott (1-800-633-9110)
state: Illinois
Study officials:
affiliation: Abbott
name: Thomas J Podsadecki, MD
role: STUDY_DIRECTOR
References: