Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00326716
First received: May 15, 2006
Last updated: November 4, 2011
Last verified: November 2011
Results First Received: January 5, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Intervention: Drug: Atazanavir + Ritonavir + Combivir

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Mother ATV 300 mg / RTV 100 mg Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
Mother ATV 400 mg / RTV 100 mg Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
Total Total of all reporting groups

Baseline Measures
    Mother ATV 300 mg / RTV 100 mg     Mother ATV 400 mg / RTV 100 mg     Total  
Number of Participants  
[units: participants]
  20     21     41  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     21     41  
>=65 years     0     0     0  
Age  
[units: Years]
Median ( Full Range )
  29  
  ( 21 to 38 )  
  28  
  ( 19 to 37 )  
  28  
  ( 19 to 38 )  
Gender  
[units: participants]
     
Female     20     21     41  
Male     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     17     19     36  
White     3     1     4  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
North America     6     6     12  
Africa     14     15     29  
HIV RNA Distribution at Baseline  
[units: c/mL]
     
<50     3     1     4  
50 to < 30,000     13     13     26  
30,000 to < 100,000     3     6     9  
>= 100,000     1     1     2  
Infant Gestational Age at Delivery  
[units: Weeks]
Median ( Full Range )
  38  
  ( 35 to 40 )  
  38  
  ( 35 to 41 )  
  38  
  ( 35 to 41 )  



  Outcome Measures
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1.  Primary:   Infant Gestational Age at Delivery   [ Time Frame: At the time of delivery ]

2.  Primary:   Infant Gender   [ Time Frame: At the time of delivery ]

3.  Primary:   Infant Race   [ Time Frame: At the time of delivery ]

4.  Primary:   Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

5.  Primary:   Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

6.  Primary:   Mean ATV Area Under the Concentration Curve (AUC TAU)   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

7.  Primary:   Mean RTV Area Under the Concentration Curve (AUC TAU)   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

8.  Primary:   Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose. ]

9.  Primary:   Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose. ]

10.  Primary:   Mean ATV Terminal Elimination Half Life (T 1/2)   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

11.  Primary:   Mean RTV Terminal Elimination Half Life (T 1/2)   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

12.  Primary:   Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum ]

13.  Primary:   Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum ]

14.  Secondary:   Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery   [ Time Frame: Day of Delivery ± 2 Days ]

15.  Secondary:   Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level   [ Time Frame: Baseline, Day of Delivery ± 2 Days ]

16.  Secondary:   Mean HIV RNA Level at Baseline   [ Time Frame: Baseline ]

17.  Secondary:   Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count   [ Time Frame: Baseline, Day of Delivery ± 2 Days ]

18.  Secondary:   Mean CD4 Cell Count at Baseline   [ Time Frame: Baseline ]

19.  Secondary:   Infant HIV Status   [ Time Frame: Birth Through 6 Months on Study ]

20.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: During study period and 30 days post-study. ]

21.  Secondary:   Number of Participants With Grade 2 to Grade 4 AEs and SAEs   [ Time Frame: During Study Period and 30 Days Post-Study. ]

22.  Secondary:   SAEs in Enrolled Mothers   [ Time Frame: During Study Period and 30 Days Post-Study. ]

23.  Secondary:   SAEs in Enrolled Infants   [ Time Frame: Birth Through Week 16 of Life ]

24.  Secondary:   Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration   [ Time Frame: At Time of Delivery ]

25.  Secondary:   Median Infant Total Bilirubin Level   [ Time Frame: Birth (Day 1), Day 3, Day 5, and Day 7 of Life ]

26.  Secondary:   Mean Atazanavir Plasma Protein Binding   [ Time Frame: Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery ]

27.  Secondary:   Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose   [ Time Frame: Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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