Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 55
- 主要终点
- Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
研究概览
简要总结
Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women.
详细描述
It is estimated that 50% of people living with HIV/AIDS worldwide are women. HIV infected women face different psychosocial issues than men, and their bodies may react differently to HIV treatment. However, most of the data on the safety and efficacy of antiretrovirals (ARVs) used in the treatment of HIV infection are from studies conducted primarily in men. LPV/r in tablet form was approved by the FDA in October 2005. This study will determine the differences in pharmacokinetics (PK) in men and women taking a soft gel capsule and a tablet formulation of LPV/r.
No ARVs will be provided by this study. In Step 1, participants will receive soft gel capsules of LPV/r. All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1. In Step 2, participants will receive tablets of LPV/r. During the study, participants in both Step 1 and 2 will take a treatment regimen of LPV/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor (NRTI), tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood collection, and clinical assessments will occur at study screening for both Steps 1 and 2. Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit. The PK visit will occur within 30 days of study screening; blood collection for PK analysis will also occur at this visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Non-nucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry
- •Require certain medications
- •Current drug or alcohol abuse that, in the investigator's opinion, may interfere with the study
- •Serious illness requiring systemic treatment or hospitalization within 30 days of study screening
- •Acute AIDS-related opportunistic infection within 90 days of study entry
结局指标
主要结局
Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
次要结局
- LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, participant's age, weight, and body mass index (BMI), and coadministration of TDF
- LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded signs and symptoms
- LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded gastrointestinal signs and symptoms (defined as nausea, vomiting, diarrhea, abdominal pain, and bloating)
- ritonavir (RTV) AUC for 0 to 12 hours, Cmax, C12h, and CL/F
- LPV/r AUC for 0 to 12 hours, Cmax, C12h, CL/F for both the soft gel capsule and tablet formulations
- LPV maximum concentration (Cmax), concentration at 12 hours (C12h), and apparent oral clearance (CL/F)
- LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and participant's race and ethnicity