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Trial record 13 of 34 for:    " May 16, 2012":" June 15, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION] AND HIV Infections

Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

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ClinicalTrials.gov Identifier: NCT01625169
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : August 7, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
LaShonda, University of Southern California

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition HIV
Intervention Drug: Etravirine pharmacokinetics in breast milk and plasma
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV + Pregnant Women
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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.

Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title HIV + Pregnant Women
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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

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
28.1
(21 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
Previous Pregnancies  
Median (Full Range)
Unit of measure:  Pregnancies
Number Analyzed 9 participants
Gravida
3
(1 to 8)
Parity
2
(0 to 6)
Abortion
1
(0 to 3)
Type of Delivery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
C-section 2
Vaginal 7
Timing of Delivery  
Measure Type: Number
Unit of measure:  Number participants
Number Analyzed 9 participants
Term 8
Preterm 1
Previous Breast Feeding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
Yes 1
No 7
[1]
Measure Description: Data only available for 8 participants.
Absolute CD4 at Delivery  
Median (Full Range)
Unit of measure:  Cells/ml
Number Analyzed 9 participants
437
(157 to 913)
1.Primary Outcome
Title Peak Plasma Concentration of Etravirine in Plasma
Hide Description

Cmax ng/ml

Note: One participant did not complete the Day 5 evaluation.

Time Frame Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note: One participant did not complete the Day 5 evaluation.
Arm/Group Title HIV + Pregnant Women
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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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/ml
497.6  (261.77)
2.Primary Outcome
Title Peak Concentration of Etravirine in Breast Milk
Hide Description

Cmax ng/ml

Note: One participant did not complete the Day 5 evaluation.

Time Frame day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note: One participant did not complete the Day 5 evaluation.
Arm/Group Title HIV + Pregnant Women
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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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/ml
685.4  (477.7)
3.Primary Outcome
Title Peak Concentration of Etravirine in Breast Milk
Hide Description Cmax ng/mL
Time Frame day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note: One participant did not complete the Day 14 evaluation.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/ml
1805.4  (1390.0)
4.Primary Outcome
Title Peak Plasma Concentration of Etravirine in Plasma
Hide Description Cmax ng/mL
Time Frame day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note: One participant did not complete the Day 14 evaluation.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/ml
564.6  (412.86)
5.Primary Outcome
Title Area Under the Curve (AUC) 0-12 for Plasma
Hide Description AUC 0-12 ng*hr/ml
Time Frame Day 5: 0, 2,4, 8 and 24 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete Day 5 visit.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
3622.1  (2020.3)
6.Primary Outcome
Title Area Under the Curve (AUC) 0-12 for Plasma
Hide Description AUC 0-12 ng*hr/ml
Time Frame Day 14: 0, 2,4, 8 and 24 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete D14 visit.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
4096  (2999.63)
7.Primary Outcome
Title Area Under the Curve (AUC) 0-12 for Breast Milk
Hide Description AUC 0-12 ng*hr/ml
Time Frame Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete D5 visit.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
4371.9  (3491.8)
8.Primary Outcome
Title Area Under the Curve (AUC) 0-12 for Breast Milk
Hide Description AUC 0-12 ng*hr/ml
Time Frame Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete D14 visit.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
12953.7  (10200.4)
9.Secondary Outcome
Title HIV Viral Load in Breast Milk and Plasma
Hide Description Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
Time Frame Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete Visit D5.
Arm/Group Title HIV + Pregnant Women
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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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Breast milk 0
Plasma 1
10.Secondary Outcome
Title HIV Viral Load in Breast Milk and Plasma
Hide Description Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
Time Frame Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete D14 visit.
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Breast milk 2
Plasma 0
Time Frame Adverse Event reporting was collecting during the study and up through the last study visit.
Adverse Event Reporting Description There were no significant toxicities or adverse events attributable to Etravirine administration in any of the subjects who received study drug. Safety labs were obtained at D14 visit. No lab toxicities were observed.
 
Arm/Group Title HIV + Pregnant Women
Hide Arm/Group Description

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.

All-Cause Mortality
HIV + Pregnant Women
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIV + Pregnant Women
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV + Pregnant Women
Affected / at Risk (%) # Events
Total   6/9 (66.67%)    
Gastrointestinal disorders   
Diarrhea  [1]  1/9 (11.11%)  1
Nervous system disorders   
Headache  [2]  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders   
Breast Tenderness  [3]  6/9 (66.67%)  6
Indicates events were collected by systematic assessment
[1]
One patient out of 9 (11%) reported diarrhea at the D5 PK visit.
[2]
1 of 9 (11%) reported a self-resolving headache on D14; not likely to be related to ETR.
[3]
66% of the subjects complained of breast tenderness related to pumping.
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
Responsible Party: LaShonda, University of Southern California
ClinicalTrials.gov Identifier: NCT01625169     History of Changes
Other Study ID Numbers: HS-09-00698
First Submitted: June 12, 2012
First Posted: June 21, 2012
Results First Submitted: June 9, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 13, 2014