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NCT01625169 · ClinicalTrials.gov registry record · NA
Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma
A NA study of HIV, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01625169: Completed NA study of HIV, sponsored by University of Southern California.
NCT01625169 is a NA study of HIV that has completed, run by University of Southern California. The registered enrollment target is 9 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625169, a NA study of HIV, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Cmax ng/ml Note: One participant did not complete the Day 5 evaluation.
Conditions Studied
Interventions
- DRUG Etravirine pharmacokinetics in breast milk and plasma
Study Locations (1)
California
- LAC+USC MCA Clinic - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01625169 record still lists
NCT01625169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (98% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Etravirine pharmacokinetics in breast milk and plasma is the first listed.
NCT01625169 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01625169 about?
NCT01625169 is a clinical study titled "Etravirine Pharmacokinetics and HIV Viral Load 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 f...
What is the current status of trial NCT01625169?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2010-04. Estimated completion is 2012-12.
What conditions does trial NCT01625169 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01625169?
The interventions under investigation include: Etravirine pharmacokinetics in breast milk and plasma (DRUG).
Who is sponsoring clinical trial NCT01625169?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01625169 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01625169's enrollment target sits among peer trials
9 300th of 303 higher than 3 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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