Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

Not Applicable

Completed

Conditions: HIV

Interventions: Drug: Etravirine pharmacokinetics in breast milk and plasma

Registration Number: NCT01625169

Lead Sponsor: University of Southern California

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 9

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV + pregnant women	Etravirine pharmacokinetics in breast milk and plasma	Etravirine pharmacokinetics in breast milk and plasma. Etravirine 200mg PO BID for 14 days with PK on days 5 and 14

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration of Etravirine in Plasma	day 14	Cmax ng/mL
Peak Concentration of Etravirine in Breast Milk	day 14	Cmax ng/mL
Area Under the Curve (AUC) 0-12 for Plasma	Day 14: 0, 2,4, 8 and 24 hours post dose	AUC 0-12 ng\*hr/ml
Area Under the Curve (AUC) 0-12 for Breast Milk	Day 14	AUC 0-12 ng\*hr/ml