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 (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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
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Los Angeles, California, États-Unis, 90033
- LAC+USC MCA Clinic
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: HIV + pregnant women
Etravirine pharmacokinetics in breast milk and plasma.
Etravirine 200mg PO BID for 14 days with PK on days 5 and 14
|
HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum.
PK will be done on postpartum days 5 and 14.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peak Plasma Concentration of Etravirine in Plasma
Délai: Day 5
|
Cmax ng/ml Note: One participant did not complete the Day 5 evaluation. |
Day 5
|
|
Peak Concentration of Etravirine in Breast Milk
Délai: day 5
|
Cmax ng/ml Note: One participant did not complete the Day 5 evaluation. |
day 5
|
|
Peak Concentration of Etravirine in Breast Milk
Délai: day 14
|
Cmax ng/mL
|
day 14
|
|
Peak Plasma Concentration of Etravirine in Plasma
Délai: day 14
|
Cmax ng/mL
|
day 14
|
|
Area Under the Curve (AUC) 0-12 for Plasma
Délai: Day 5: 0, 2,4, 8 and 24 hours post dose
|
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
Délai: Day 14: 0, 2,4, 8 and 24 hours post dose
|
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
Délai: Day 5
|
AUC 0-12 ng*hr/ml
|
Day 5
|
|
Area Under the Curve (AUC) 0-12 for Breast Milk
Délai: Day 14
|
AUC 0-12 ng*hr/ml
|
Day 14
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
HIV Viral Load in Breast Milk and Plasma
Délai: Day 5
|
Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
|
Day 5
|
|
HIV Viral Load in Breast Milk and Plasma
Délai: Day 14
|
Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
|
Day 14
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: LaShonda Y Spencer, MD, University of Southern California
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HS-09-00698
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