HIVNCT01625169
Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma
A study testing Etravirine pharmacokinetics in breast milk and plasma in people with HIV, run by University of Southern California at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Etravirine pharmacokinetics in breast milk and plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiretroviral Drug Concentrations and HIV Viral Load in Breast Milk and Plasma in HIV+ Women Receiving HAART (Highly Active Antiretroviral Therapy) Therapy: Etravirine (ETR) Pharmacokinetics (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 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
- Being tested
- Etravirine pharmacokinetics in breast milk and plasma
- Keywords
- Pharmacokinetics, HIV, Breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etravirine pharmacokinetics in breast milk and plasmaDrug
HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum. PK will be done on postpartum days 5 and 14.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Etravirine pharmacokinetics in breast milk and plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration of Etravirine in Plasma
Cmax ng/ml
Note: One participant did not complete the Day 5 evaluation.
Measured: Day 5
Peak Concentration of Etravirine in Breast Milk
Cmax ng/ml
Note: One participant did not complete the Day 5 evaluation.
Measured: day 5
Peak Concentration of Etravirine in Breast Milk
Cmax ng/mL
Measured: day 14
Peak Plasma Concentration of Etravirine in Plasma
Cmax ng/mL
Measured: day 14
Area Under the Curve (AUC) 0-12 for Plasma
AUC 0-12 ng*hr/ml
Measured: 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
Measured: 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
Measured: Day 5
Area Under the Curve (AUC) 0-12 for Breast Milk
AUC 0-12 ng*hr/ml
Measured: Day 14
Secondary outcomes (2)
HIV Viral Load in Breast Milk and Plasma
Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
Measured: Day 5
HIV Viral Load in Breast Milk and Plasma
Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Responsible party
- Principal investigator, LaShonda, University of Southern California
- Investigators
- LaShonda Y Spencer, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625169
- Sponsor's protocol ID
- HS-09-00698
- Status last verified
- Aug 2014
- First submitted
- 12 Jun 2012
- Last updated
- 13 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Drug Concentrations and HIV Viral Load in Breast Milk and Plasma in HIV+ Women Receiving HAART (Highly Active Antiretroviral Therapy) Therapy: Etravirine (ETR) Pharmacokinetics (PK) in Breast Milk and Plasma
- ClinicalTrials.gov ID
- NCT01625169
- Acronym / sponsor ID
- HS-09-00698
- Conditions
- HIV
- Keywords
- Pharmacokinetics, HIV, Breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV + pregnant women | Other | Drug: Etravirine pharmacokinetics in breast milk and plasmaEtravirine pharmacokinetics in breast milk and plasma. Etravirine 200mg PO BID for 14 days with PK on days 5 and 14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnant women with medical or psychological contraindications to breast milk expression.
- Requirements for prohibited medications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etravirine pharmacokinetics in breast milk and plasmaHIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum. PK will be done on postpartum days 5 and 14. | Drug | HIV + pregnant women |
Primary outcome
Peak Plasma Concentration of Etravirine in Plasma
Time frame: Day 5
Cmax ng/ml Note: One participant did not complete the Day 5 evaluation.
Peak Concentration of Etravirine in Breast Milk
Time frame: day 5
Cmax ng/ml Note: One participant did not complete the Day 5 evaluation.
Peak Concentration of Etravirine in Breast Milk
Time frame: day 14
Cmax ng/mL
Peak Plasma Concentration of Etravirine in Plasma
Time frame: day 14
Cmax ng/mL
Area Under the Curve (AUC) 0-12 for Plasma
Time frame: Day 5: 0, 2,4, 8 and 24 hours post dose
AUC 0-12 ng*hr/ml
Area Under the Curve (AUC) 0-12 for Plasma
Time frame: 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
Time frame: Day 5
AUC 0-12 ng*hr/ml
Area Under the Curve (AUC) 0-12 for Breast Milk
Time frame: Day 14
AUC 0-12 ng*hr/ml
2 secondary outcomes
HIV Viral Load in Breast Milk and Plasma
Time frame: Day 5
HIV Viral Load in Breast Milk and Plasma
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LaShonda Y Spencer, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etravirine pharmacokinetics in breast milk and plasma in people with HIV, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration of Etravirine in Plasma (time frame: Day 5). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.