Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

NCT01625169 | Completed Results

• 1 other identifier: HS-09-00698
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Pharmacokinetics; HIV; Breast milk

Outcome Measures

Primary Outcomes (8)

• Peak Plasma Concentration of Etravirine in Plasma

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

  Day 5

• Peak Concentration of Etravirine in Breast Milk

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

  day 5

• Peak Concentration of Etravirine in Breast Milk

  Cmax ng/mL

  day 14

• Peak Plasma Concentration of Etravirine in Plasma

  Cmax ng/mL

  day 14

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

  AUC 0-12 ng\*hr/ml

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

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

  AUC 0-12 ng\*hr/ml

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

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

  AUC 0-12 ng\*hr/ml

  Day 5

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

  AUC 0-12 ng\*hr/ml

  Day 14

Secondary Outcomes (2)

• HIV Viral Load in Breast Milk and Plasma

  Day 5

• HIV Viral Load in Breast Milk and Plasma

  Day 14

Study Arms (1)

HIV + pregnant women

OTHER

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

Etravirine pharmacokinetics in breast milk and plasma DRUG

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

HIV + pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ pregnant women on HAART for the prevention of MTCT w/ undetectable viral load at time of delivery (w/i 30 days of delivery).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA: collaborator

Study Sites (1)

LAC+USC MCA Clinic

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Results Point of Contact

• Title: LaShonda Spencer
• Organization: USC

lspencer@usc.edu

323 226-6437

Study Officials

• LaShonda Y Spencer, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Clinical Pediatrics

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 21, 2012
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 13, 2014
• Results First Posted: August 7, 2014

Record last verified: 2014-08

Locations

US (1)