Trial Outcomes & Findings for Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma (NCT NCT01625169)

NCT ID: NCT01625169

Last Updated: 2014-08-13

Results Overview

Cmax ng/ml Note: One participant did not complete the Day 5 evaluation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Day 5
• Results posted on: 2014-08-13

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

Baseline characteristics by cohort

Measure	HIV + Pregnant Women n=9 Participants 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
Age, Continuous	28.1 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	9 participants n=93 Participants
Previous Pregnancies Gravida	3 pregnancies n=93 Participants
Previous Pregnancies Parity	2 pregnancies n=93 Participants
Previous Pregnancies Abortion	1 pregnancies n=93 Participants
Type of Delivery C-section	2 participants n=93 Participants
Type of Delivery Vaginal	7 participants n=93 Participants
Timing of Delivery Term	8 number participants n=93 Participants
Timing of Delivery Preterm	1 number participants n=93 Participants
Previous Breast Feeding Yes	1 participants n=93 Participants
Previous Breast Feeding No	7 participants n=93 Participants
Absolute CD4 at Delivery	437 cells/ml n=93 Participants

PRIMARY outcome

Timeframe: Day 5

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

Cmax ng/ml

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

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Peak Plasma Concentration of Etravirine in Plasma	497.6 ng/ml Standard Deviation 261.77

PRIMARY outcome

Timeframe: day 5

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

Cmax ng/ml

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

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Peak Concentration of Etravirine in Breast Milk	685.4 ng/ml Standard Deviation 477.7

PRIMARY outcome

Timeframe: day 14

Population: Note: One participant did not complete the Day 14 evaluation.

Cmax ng/mL

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Peak Concentration of Etravirine in Breast Milk	1805.4 ng/ml Standard Deviation 1390.0

PRIMARY outcome

Timeframe: day 14

Population: Note: One participant did not complete the Day 14 evaluation.

Cmax ng/mL

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Peak Plasma Concentration of Etravirine in Plasma	564.6 ng/ml Standard Deviation 412.86

PRIMARY outcome

Timeframe: Day 5: 0, 2,4, 8 and 24 hours post dose

Population: One participant did not complete Day 5 visit.

AUC 0-12 ng*hr/ml

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Area Under the Curve (AUC) 0-12 for Plasma	3622.1 ng*hr/ml Standard Deviation 2020.3

PRIMARY outcome

Timeframe: Day 14: 0, 2,4, 8 and 24 hours post dose

Population: One participant did not complete D14 visit.

AUC 0-12 ng*hr/ml

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Area Under the Curve (AUC) 0-12 for Plasma	4096 ng*hr/ml Standard Deviation 2999.63

PRIMARY outcome

Timeframe: Day 5

Population: One participant did not complete D5 visit.

AUC 0-12 ng*hr/ml

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Area Under the Curve (AUC) 0-12 for Breast Milk	4371.9 ng*hr/ml Standard Deviation 3491.8

PRIMARY outcome

Timeframe: Day 14

Population: One participant did not complete D14 visit.

AUC 0-12 ng*hr/ml

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
Area Under the Curve (AUC) 0-12 for Breast Milk	12953.7 ng*hr/ml Standard Deviation 10200.4

SECONDARY outcome

Timeframe: Day 5

Population: One participant did not complete Visit D5.

Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
HIV Viral Load in Breast Milk and Plasma Breast milk	0 participants
HIV Viral Load in Breast Milk and Plasma Plasma	1 participants

SECONDARY outcome

Timeframe: Day 14

Population: One participant did not complete D14 visit.

Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml

Outcome measures

Measure	HIV + Pregnant Women n=8 Participants 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.
HIV Viral Load in Breast Milk and Plasma Breast milk	2 participants
HIV Viral Load in Breast Milk and Plasma Plasma	0 participants

Adverse Events

HIV + Pregnant Women

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HIV + Pregnant Women n=9 participants at risk 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.
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Adverse Event reporting was collecting during the study and up through the last study visit. 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.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Adverse Event reporting was collecting during the study and up through the last study visit. 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.
Skin and subcutaneous tissue disorders Breast Tenderness	66.7% 6/9 • Number of events 6 • Adverse Event reporting was collecting during the study and up through the last study visit. 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.

Additional Information

LaShonda Spencer

USC

Phone: 323 226-6437

Email: lspencer@usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place