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: December 30, 2013
Last verified: December 2013

June 12, 2012
December 30, 2013
April 2010
December 2012   (final data collection date for primary outcome measure)
  • Peak plasma Concentration of Etravirine in plasma [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Cmax ng/ml
  • Peak Plasma Concentration of Etravirine in Breast milk [ Time Frame: day 5 ] [ Designated as safety issue: No ]
    Cmax ng/ml
  • Peak Plasma Concentration of Etravirine in Breast milk [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    Cmax ng/mL
  • Peak Plasma Concentration of Etravirine in plasma [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    Cmax ng/mL
  • Area under the curve (AUC) 0-12 for Plasma [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    AUC 0-12 ng*hr/ml
  • Area under the curve (AUC) 0-12 for Plasma [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    AUC 0-12 ng*hr/ml
  • Area under the curve (AUC) 0-12 for Breast milk [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    AUC 0-12 ng*hr/ml
  • Area under the curve (AUC) 0-12 for Breast milk [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    AUC 0-12 ng*hr/ml
Pharmacokinetics of ETR in breast milk and plasma. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
AUC for both breast milk and plasma will be measured. In addition, concentrations in early milk (D5) will be compared to late milk (D14).
Complete list of historical versions of study NCT01625169 on ClinicalTrials.gov Archive Site
  • HIV viral load in Breast milk and plasma [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    HIV RNA copies/mL
  • HIV viral load in Breast milk and plasma [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    HIV RNA copies/mL
HIV viral load in Breast milk and plasma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
To compare HIV viral load in breast milk and plasma.
Not Provided
Not Provided
 
Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma
Antiretroviral Drug Concentrations and HIV Viral Load in Breast Milk and Plasma in HIV+ Women Receiving HAART Therapy: Etravirine PK in Breast Milk and Plasma

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 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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV
Drug: 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 + pregnant women
Etravirine PK on days 5 and 14
Intervention: Drug: Etravirine pharmacokinetics in breast milk and plasma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
December 2012
December 2012   (final data collection date for primary outcome measure)

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:

  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, NNRTIs.
    • Alternative/CAM: St. John's wort
    • Anticonvulsants: Phenobarbital, carbamazepine , phenytoin
    • Anti-infectives: Rifampin
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01625169
HS-09-00698
No
LaShonda, University of Southern California
University of Southern California
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Principal Investigator: LaShonda Y Spencer, MD University of Southern California
University of Southern California
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP