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Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
LaShonda, University of Southern California
ClinicalTrials.gov Identifier:
NCT01625169
First received: June 12, 2012
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: June 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: HIV
Intervention: Drug: Etravirine pharmacokinetics in breast milk and plasma

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HIV + Pregnant Women

Etravirine PK on days 5 and 14

Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.


Participant Flow:   Overall Study
    HIV + Pregnant Women  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  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
HIV + Pregnant Women

Etravirine PK on days 5 and 14

Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.

There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum


Baseline Measures
    HIV + Pregnant Women  
Number of Participants  
[units: participants]
  9  
Age  
[units: years]
Median ( Full Range )
  28.1  
  ( 21 to 38 )  
Gender  
[units: participants]
 
Female     9  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     9  
Previous Pregnancies  
[units: pregnancies]
Median ( Full Range )
 
Gravida     3  
  ( 1 to 8 )  
Parity     2  
  ( 0 to 6 )  
Abortion     1  
  ( 0 to 3 )  
Type of Delivery  
[units: participants]
 
C-section     2  
Vaginal     7  
Timing of Delivery  
[units: number┬áparticipants]
 
Term     8  
Preterm     1  
Previous Breast Feeding [1]
[units: participants]
 
Yes     1  
No     7  
Absolute CD4 at Delivery  
[units: cells/ml]
Median ( Full Range )
  437  
  ( 157 to 913 )  
[1] Data only available for 8 participants.



  Outcome Measures
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1.  Primary:   Peak Plasma Concentration of Etravirine in Plasma   [ Time Frame: Day 5 ]

2.  Primary:   Peak Concentration of Etravirine in Breast Milk   [ Time Frame: day 5 ]

3.  Primary:   Peak Concentration of Etravirine in Breast Milk   [ Time Frame: day 14 ]

4.  Primary:   Peak Plasma Concentration of Etravirine in Plasma   [ Time Frame: day 14 ]

5.  Primary:   Area Under the Curve (AUC) 0-12 for Plasma   [ Time Frame: Day 5: 0, 2,4, 8 and 24 hours post dose ]

6.  Primary:   Area Under the Curve (AUC) 0-12 for Plasma   [ Time Frame: Day 14: 0, 2,4, 8 and 24 hours post dose ]

7.  Primary:   Area Under the Curve (AUC) 0-12 for Breast Milk   [ Time Frame: Day 5 ]

8.  Primary:   Area Under the Curve (AUC) 0-12 for Breast Milk   [ Time Frame: Day 14 ]

9.  Secondary:   HIV Viral Load in Breast Milk and Plasma   [ Time Frame: Day 5 ]

10.  Secondary:   HIV Viral Load in Breast Milk and Plasma   [ Time Frame: Day 14 ]


  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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: LaShonda Spencer
Organization: USC
phone: 323 226-6437
e-mail: lspencer@usc.edu


No publications provided


Responsible Party: LaShonda, University of Southern California
ClinicalTrials.gov Identifier: NCT01625169     History of Changes
Other Study ID Numbers: HS-09-00698
Study First Received: June 12, 2012
Results First Received: June 9, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration