Phase 1
Completed N=41
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
HIV Infection
Source: ClinicalTrials.gov NCT00326716 ↗
Enrolled (actual)
41
Serious AEs
35.8%
Results posted
Apr 2011
Primary outcomePrimary: Infant Gestational Age at Delivery — 38; 38 Weeks
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infant Gestational Age at Delivery |
38; 38 | — |
| PRIMARY Infant Gender |
12; 9; 8; 11 | — |
| PRIMARY Infant Race |
15; 18; 5; 1; 0; 1 | — |
| PRIMARY Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval |
3,729.09; 3,291.46; 4,210.76 | — |
| PRIMARY Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval |
530.81; 587.36; 524.48 | — |
| PRIMARY Mean ATV Area Under the Concentration Curve (AUC TAU) |
34,399.13; 34,251.50; 46,602.45 | — |
| PRIMARY Mean RTV Area Under the Concentration Curve (AUC TAU) |
4,500.03; 4,664.93; 4,383.30 | — |
| PRIMARY Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose |
663.78; 668.48; 916.63 | — |
| PRIMARY Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose |
50.10; 41.12; 38.05 | — |
| PRIMARY Mean ATV Terminal Elimination Half Life (T 1/2) |
10.42; 12.10; 12.17 | — |
| PRIMARY Mean RTV Terminal Elimination Half Life (T 1/2) |
5.03; 5.28; 5.10 | — |
| PRIMARY Mean ATV Time of Maximum Observed Plasma Concentration (Tmax) |
3.68; 2.94; 3.30 | — |
| PRIMARY Mean RTV Time of Maximum Observed Plasma Concentration (Tmax) |
6.11; 4.15; 4.63 | — |
| SECONDARY Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery |
19; 20; 19; 19 | — |
| SECONDARY Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level |
-1.8; -2.37 | — |
| SECONDARY Mean HIV RNA Level at Baseline |
3.520; 4.020 | — |
| SECONDARY Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count |
89; 174 | — |
| SECONDARY Mean CD4 Cell Count at Baseline |
435.0; 390.0 | — |
| SECONDARY Infant HIV Status |
0; 0; 20; 20 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
0; 0; 16; 14; 2; 2 | — |
| SECONDARY Number of Participants With Grade 2 to Grade 4 AEs and SAEs |
32; 19; 10; 0; 12; 8 | — |
| SECONDARY SAEs in Enrolled Mothers |
7; 8; 1; 2; 1; 2 | — |
| SECONDARY SAEs in Enrolled Infants |
10; 4; 1; 1; 1; 1 | — |
| SECONDARY Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration |
1,412.05; 1,568.06; 273.20; 231.49 | — |
| SECONDARY Median Infant Total Bilirubin Level |
3.20; 3.25; 8.40; 9.20; 7.10; 9.25 | — |
| SECONDARY Mean Atazanavir Plasma Protein Binding |
91.34; 87.70; 90.37; 88.89; 77.05; 75.62 | — |
| SECONDARY Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose |
20; 17; 20; 17; 20; 17 | — |
Eligibility Criteria
Inclusion Criteria
- 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 400 c/mL
Data sourced from ClinicalTrials.gov (NCT00326716). 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.