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CompletedNCT01625169Updated Aug 13, 2014Results posted

Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

An interventional study of Etravirine pharmacokinetics in breast milk and plasma in HIV, sponsored by University of Southern California. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-13.

Sponsored by University of Southern California · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

HIV positive pregnant women who receive potent combination antiretroviral therapy over at least the last trimester of pregnancy, and who have proper obstetric interventions and are able to avoid breast feeding, decrease the risk of having an infected infant to about 1%. Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk transmission, and a 2-fold increased risk of transmission associated with every 10-fold increase in breast milk viral load has been reported. In addition, cell associated virus (HIV DNA) was associated with a significant increase in risk of transmission independent of the level of cell-free viral RNA.

However, multiple studies of HIV positive women giving birth have shown that exclusive breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding (defined as breast milk along with complementary food, other milk, and/or infant formula). The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal is to determine how much etravirine penetrates into breast milk, and whether it leads to undetectable HIV viral load in the breast milk and therefore has the potential to decrease the risk of transmission of HIV through breast milk. The long term goal is to see if breast milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT) of HIV in infants receiving only breast feeding in resource poor areas.

02

Conditions studied

  • HIV

Keywords

  • Pharmacokinetics
  • HIV
  • Breast milk
03

In context

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. HIV+ pregnant women on HAART for the prevention of MTCT w/ undetectable viral load at time of delivery (w/i 30 days of delivery).
  2. 18 years and older
  3. Only women who are deemed by the physician as being capable of understanding that HIV positive women should not breastfeed will be approached.
  4. Life expectancy greater than 6 months
  5. No known allergies to etravirine
  6. Willingness of subject to adhere to protocol requirements.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant women with medical or psychological contraindications to breast milk expression.

  2. Requirements for prohibited medications:

    • ARV: Tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, and protease inhibitors administered without ritonavir, nonnucleoside reverse transcriptase inhibitor (NNRTIs).
    • Alternative/CAM: St. John's wort
    • Anticonvulsants: Phenobarbital, carbamazepine , phenytoin
    • Anti-infectives: Rifampin
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Other
    HIV + pregnant women

    Etravirine pharmacokinetics in breast milk and plasma. Etravirine 200mg PO BID for 14 days with PK on days 5 and 14

    Drug: Etravirine pharmacokinetics in breast milk and plasma

Interventions

  • DrugEtravirine pharmacokinetics in breast milk and plasma

    HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum. PK will be done on postpartum days 5 and 14.

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration of Etravirine in Plasma

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

    Time frame: Day 5

  2. Peak Concentration of Etravirine in Breast Milk

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

    Time frame: day 5

  3. Peak Concentration of Etravirine in Breast Milk

    Cmax ng/mL

    Time frame: day 14

  4. Peak Plasma Concentration of Etravirine in Plasma

    Cmax ng/mL

    Time frame: day 14

  5. Area Under the Curve (AUC) 0-12 for Plasma

    AUC 0-12 ng\*hr/ml

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

  6. Area Under the Curve (AUC) 0-12 for Plasma

    AUC 0-12 ng\*hr/ml

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

  7. Area Under the Curve (AUC) 0-12 for Breast Milk

    AUC 0-12 ng\*hr/ml

    Time frame: Day 5

  8. Area Under the Curve (AUC) 0-12 for Breast Milk

    AUC 0-12 ng\*hr/ml

    Time frame: Day 14

Secondary outcomes

  1. HIV Viral Load in Breast Milk and Plasma

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

    Time frame: Day 5

  2. HIV Viral Load in Breast Milk and Plasma

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

    Time frame: Day 14

07

Results

Posted Aug 7, 2014

Participant flow

Participant flow — Overall Study
MilestoneHIV + Pregnant Women
Started9
Completed9
Not completed0

Outcome measures

PrimaryPeak Plasma Concentration of Etravirine in Plasma

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

Time frame:
Day 5
Reported as:
Mean · ng/ml
Peak Plasma Concentration of Etravirine in Plasma
ng/mlHIV + Pregnant Women
Peak Plasma Concentration of Etravirine in Plasma497.6 ± 261.77
PrimaryPeak Concentration of Etravirine in Breast Milk

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

Time frame:
day 5
Reported as:
Mean · ng/ml
Peak Concentration of Etravirine in Breast Milk
ng/mlHIV + Pregnant Women
Peak Concentration of Etravirine in Breast Milk685.4 ± 477.7
PrimaryPeak Concentration of Etravirine in Breast Milk

Cmax ng/mL

Time frame:
day 14
Reported as:
Mean · ng/ml
Peak Concentration of Etravirine in Breast Milk
ng/mlHIV + Pregnant Women
Peak Concentration of Etravirine in Breast Milk1805.4 ± 1390.0
PrimaryPeak Plasma Concentration of Etravirine in Plasma

Cmax ng/mL

Time frame:
day 14
Reported as:
Mean · ng/ml
Peak Plasma Concentration of Etravirine in Plasma
ng/mlHIV + Pregnant Women
Peak Plasma Concentration of Etravirine in Plasma564.6 ± 412.86
PrimaryArea Under the Curve (AUC) 0-12 for Plasma

AUC 0-12 ng\*hr/ml

Time frame:
Day 5: 0, 2,4, 8 and 24 hours post dose
Reported as:
Mean · ng*hr/ml
Area Under the Curve (AUC) 0-12 for Plasma
ng*hr/mlHIV + Pregnant Women
Area Under the Curve (AUC) 0-12 for Plasma3622.1 ± 2020.3
PrimaryArea Under the Curve (AUC) 0-12 for Plasma

AUC 0-12 ng\*hr/ml

Time frame:
Day 14: 0, 2,4, 8 and 24 hours post dose
Reported as:
Mean · ng*hr/ml
Area Under the Curve (AUC) 0-12 for Plasma
ng*hr/mlHIV + Pregnant Women
Area Under the Curve (AUC) 0-12 for Plasma4096 ± 2999.63
PrimaryArea Under the Curve (AUC) 0-12 for Breast Milk

AUC 0-12 ng\*hr/ml

Time frame:
Day 5
Reported as:
Mean · ng*hr/ml
Area Under the Curve (AUC) 0-12 for Breast Milk
ng*hr/mlHIV + Pregnant Women
Area Under the Curve (AUC) 0-12 for Breast Milk4371.9 ± 3491.8
PrimaryArea Under the Curve (AUC) 0-12 for Breast Milk

AUC 0-12 ng\*hr/ml

Time frame:
Day 14
Reported as:
Mean · ng*hr/ml
Area Under the Curve (AUC) 0-12 for Breast Milk
ng*hr/mlHIV + Pregnant Women
Area Under the Curve (AUC) 0-12 for Breast Milk12953.7 ± 10200.4
SecondaryHIV Viral Load in Breast Milk and Plasma

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

Time frame:
Day 5
Reported as:
Number · participants
HIV Viral Load in Breast Milk and Plasma
participantsHIV + Pregnant Women
Breast milk0
Plasma1
SecondaryHIV Viral Load in Breast Milk and Plasma

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

Time frame:
Day 14
Reported as:
Number · participants
HIV Viral Load in Breast Milk and Plasma
participantsHIV + Pregnant Women
Breast milk2
Plasma0

Adverse events

Collected over Adverse Event reporting was collecting during the study and up through the last study visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HIV + Pregnant Women—0/9 (0%)6/9 (66.7%)
Most frequent other events
Most frequent other events
EventHIV + Pregnant Women
Breast TendernessSkin and subcutaneous tissue disorders6/9
DiarrheaGastrointestinal disorders1/9
HeadacheNervous system disorders1/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)HIV + Pregnant Women
Median28.1 (21 to 38)
Sex: Female, Male
Sex: Female, Male(Participants)HIV + Pregnant Women
Female9
Male0
Region of Enrollment
Region of Enrollment(participants)HIV + Pregnant Women
United States9
Previous Pregnancies
Previous Pregnancies(pregnancies)HIV + Pregnant Women
Gravida3 (1 to 8)
Parity2 (0 to 6)
Abortion1 (0 to 3)
Type of Delivery
Type of Delivery(participants)HIV + Pregnant Women
C-section2
Vaginal7
Timing of Delivery
Timing of Delivery(number participants)HIV + Pregnant Women
Term8
Preterm1
Previous Breast Feeding
Previous Breast Feeding(participants)HIV + Pregnant Women
Yes1
No7
Absolute CD4 at Delivery
Absolute CD4 at Delivery(cells/ml)HIV + Pregnant Women
Median437 (157 to 913)
08

Study locations

1 site
  • LAC+USC MCA Clinic
    Los Angeles, California 90033, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01625169
Lead sponsor
University of Southern California
Collaborators
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Responsible party
LaShonda (Assistant Prof of Clinical Pediatrics, University of Southern California) — Principal investigator
First posted
Jun 21, 2012
Start date
Apr 2010
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Aug 7, 2014
Last update
Aug 13, 2014

Study contacts

LaShonda Y Spencer, MD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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