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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90033
- LAC+USC MCA Clinic
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: HIV + pregnant women
Etravirine pharmacokinetics in breast milk and plasma.
Etravirine 200mg PO BID for 14 days with PK on days 5 and 14
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HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum.
PK will be done on postpartum days 5 and 14.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Peak Plasma Concentration of Etravirine in Plasma
Prazo: Day 5
|
Cmax ng/ml Note: One participant did not complete the Day 5 evaluation. |
Day 5
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Peak Concentration of Etravirine in Breast Milk
Prazo: day 5
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Cmax ng/ml Note: One participant did not complete the Day 5 evaluation. |
day 5
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Peak Concentration of Etravirine in Breast Milk
Prazo: day 14
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Cmax ng/mL
|
day 14
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Peak Plasma Concentration of Etravirine in Plasma
Prazo: day 14
|
Cmax ng/mL
|
day 14
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Area Under the Curve (AUC) 0-12 for Plasma
Prazo: Day 5: 0, 2,4, 8 and 24 hours post dose
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AUC 0-12 ng*hr/ml
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Day 5: 0, 2,4, 8 and 24 hours post dose
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Area Under the Curve (AUC) 0-12 for Plasma
Prazo: Day 14: 0, 2,4, 8 and 24 hours post dose
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AUC 0-12 ng*hr/ml
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Day 14: 0, 2,4, 8 and 24 hours post dose
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Area Under the Curve (AUC) 0-12 for Breast Milk
Prazo: Day 5
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AUC 0-12 ng*hr/ml
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Day 5
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Area Under the Curve (AUC) 0-12 for Breast Milk
Prazo: Day 14
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AUC 0-12 ng*hr/ml
|
Day 14
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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HIV Viral Load in Breast Milk and Plasma
Prazo: Day 5
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Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
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Day 5
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HIV Viral Load in Breast Milk and Plasma
Prazo: Day 14
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Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml
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Day 14
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: LaShonda Y Spencer, MD, University of Southern California
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HS-09-00698
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