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| Name | Class |
|---|---|
| Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Viral Load in Breast Milk and Plasma | Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml | Day 5 |
| HIV Viral Load in Breast Milk and Plasma | Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women with medical or psychological contraindications to breast milk expression.
Requirements for prohibited medications:
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| Name | Affiliation | Role |
|---|---|---|
| LaShonda Y Spencer, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC+USC MCA Clinic | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Plasma Concentration of Etravirine in Plasma | Cmax ng/ml Note: One participant did not complete the Day 5 evaluation. | Note: One participant did not complete the Day 5 evaluation. | Posted | Mean | Standard Deviation | ng/ml | Day 5 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | One patient out of 9 (11%) reported diarrhea at the D5 PK visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LaShonda Spencer | USC | 323 226-6437 | lspencer@usc.edu |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Day 14 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Previous Pregnancies | Median | Full Range | pregnancies |
|
| Type of Delivery | Number | participants |
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| Timing of Delivery | Number | number participants |
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| Previous Breast Feeding | Data only available for 8 participants. | Number | participants |
|
| Absolute CD4 at Delivery | Median | Full Range | cells/ml |
|
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| Primary | Peak Concentration of Etravirine in Breast Milk | Cmax ng/ml Note: One participant did not complete the Day 5 evaluation. | Note: One participant did not complete the Day 5 evaluation. | Posted | Mean | Standard Deviation | ng/ml | day 5 |
|
|
|
| Primary | Peak Concentration of Etravirine in Breast Milk | Cmax ng/mL | Note: One participant did not complete the Day 14 evaluation. | Posted | Mean | Standard Deviation | ng/ml | day 14 |
|
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|
| Primary | Peak Plasma Concentration of Etravirine in Plasma | Cmax ng/mL | Note: One participant did not complete the Day 14 evaluation. | Posted | Mean | Standard Deviation | ng/ml | day 14 |
|
|
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| Primary | Area Under the Curve (AUC) 0-12 for Plasma | AUC 0-12 ng*hr/ml | One participant did not complete Day 5 visit. | Posted | Mean | Standard Deviation | ng*hr/ml | Day 5: 0, 2,4, 8 and 24 hours post dose |
|
|
|
| Primary | Area Under the Curve (AUC) 0-12 for Plasma | AUC 0-12 ng*hr/ml | One participant did not complete D14 visit. | Posted | Mean | Standard Deviation | ng*hr/ml | Day 14: 0, 2,4, 8 and 24 hours post dose |
|
|
|
| Primary | Area Under the Curve (AUC) 0-12 for Breast Milk | AUC 0-12 ng*hr/ml | One participant did not complete D5 visit. | Posted | Mean | Standard Deviation | ng*hr/ml | Day 5 |
|
|
|
| Primary | Area Under the Curve (AUC) 0-12 for Breast Milk | AUC 0-12 ng*hr/ml | One participant did not complete D14 visit. | Posted | Mean | Standard Deviation | ng*hr/ml | Day 14 |
|
|
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| Secondary | HIV Viral Load in Breast Milk and Plasma | Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml | One participant did not complete Visit D5. | Posted | Number | participants | Day 5 |
|
|
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| Secondary | HIV Viral Load in Breast Milk and Plasma | Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml | One participant did not complete D14 visit. | Posted | Number | participants | Day 14 |
|
|
|
| 0 |
| 9 |
| 6 |
| 9 |
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| Headache | Nervous system disorders | Systematic Assessment | 1 of 9 (11%) reported a self-resolving headache on D14; not likely to be related to ETR. |
|
| Breast Tenderness | Skin and subcutaneous tissue disorders | Systematic Assessment | 66% of the subjects complained of breast tenderness related to pumping. |
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| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |