A Study of the Pharmacokinetics of Atazanavir (ATV)/Ritonavir(RTV) Administered as Part of Highly Active Antiretroviral Therapy (HAART) in HIV-1 Infected Pregnant Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- Infant Gestational Age at Delivery
研究概览
简要总结
To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV-infected pregnant women
- •> 18 years of age
- •Between week 12 and 32 gestation
- •CD4 > 200 cells/mm³
- •Treatment-naive with HIV RNA > 400 c/mL, on HAART with HIV RNA <50 c/mL, or previously treated with ATV (< 3 weeks) with HIV RNA>400 c/mL
排除标准
- 未提供
研究组 & 干预措施
Treatment
干预措施: Atazanavir + Ritonavir + Combivir (Drug)
结局指标
主要结局
Infant Gestational Age at Delivery
时间窗: At the time of delivery
Infant Gender
时间窗: At the time of delivery
Infant Race
时间窗: At the time of delivery
Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Cmax = maximum observed plasma concentration of atazanavir at specified time points.
Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Cmax = maximum observed plasma concentration of ritonavir at specified time points.
Mean ATV Area Under the Concentration Curve (AUC TAU)
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
AUC = area under the concentration curve (AUC \[TAU\]) of atazanavir in one dosing interval from time zero to 24 hours.
Mean RTV Area Under the Concentration Curve (AUC TAU)
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
AUC = area under the concentration curve (AUC \[TAU\]) of ritonavir in one dosing interval.
Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.
Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.
Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.
Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.
Mean ATV Terminal Elimination Half Life (T 1/2)
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
T 1/2 = terminal elimination half life of atazanavir at specified time points.
Mean RTV Terminal Elimination Half Life (T 1/2)
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
T 1/2 = terminal elimination half life of ritonavir at specified time points.
Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)
时间窗: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.
Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)
时间窗: Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum
Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.
次要结局
- Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery(Day of Delivery ± 2 Days)
- Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level(Baseline, Day of Delivery ± 2 Days)
- Mean HIV RNA Level at Baseline(Baseline)
- Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count(Baseline, Day of Delivery ± 2 Days)
- Mean CD4 Cell Count at Baseline(Baseline)
- Infant HIV Status(Birth Through 6 Months on Study)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(During study period and 30 days post-study.)
- Number of Participants With Grade 2 to Grade 4 AEs and SAEs(During Study Period and 30 Days Post-Study.)
- SAEs in Enrolled Mothers(During Study Period and 30 Days Post-Study.)
- SAEs in Enrolled Infants(Birth Through Week 16 of Life)
- Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration(At Time of Delivery)
- Median Infant Total Bilirubin Level(Birth (Day 1), Day 3, Day 5, and Day 7 of Life)
- Mean Atazanavir Plasma Protein Binding(Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery)
- Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose(Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum)