Last updated on December 2018

Evaluating the Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection


Brief description of study

This study will evaluate the safety, tolerability, and pharmacokinetics of maraviroc in infants at risk for mother-to-child HIV transmission and determine an appropriate dose of maraviroc during the first 6 weeks of life.

Detailed Study Description

Maraviroc is a CCR5 receptor antagonist used to treat HIV infection in adults. Adding maraviroc to a standard of care prophylaxis regimen may also reduce the risk of perinatal transmission of HIV. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of maraviroc in HIV-1-exposed infants at risk for mother-to-child HIV transmission. This study will also determine an appropriate dose of maraviroc during the first 6 weeks of life.

The study will enroll up to 72 mother-infant pairs in two cohorts. Because maraviroc interacts with the antiretroviral drug efavirenz (EFV) in adults, infants in this study will be stratified within the cohorts based on their exposure to maternal EFV. Cohort 1 will be stratified by in utero exposure to maternal EFV, with infants in both strata receiving a single dose of maraviroc solution within 3 days of birth and another single dose at Week 1 of life. Stratum 1A includes infants without in utero exposure to maternal EFV during the 8 weeks immediately before delivery. Stratum 1B includes infants with in utero exposure to maternal EFV for a minimum of 2 weeks immediately before delivery.

Cohort 2 will be stratified by exposure to maternal EFV after birth, with infants in both strata receiving maraviroc oral solution twice daily starting within 3 days of birth and continuing for up to 42 days. Based on evaluation of the Cohort 1 data, the initial daily dose of maraviroc oral solution to be administered in Cohort 2 will be 8 mg/kg dose given twice daily. Stratum 2A includes infants without any exposure to maternal EFV either in utero during the 8 weeks immediately before delivery or while breastfeeding. Stratum 2B includes breastfeeding infants with exposure to maternal EFV both in utero and after birth while breastfeeding, for a minimum of 2 weeks immediately before delivery and while breastfeeding.

Participants will attend an entry visit within 3 days after the infant's birth. Participants will attend 5 to 6 study visits through Month 4. Visits may include medical history reviews, physical examinations, blood collection from the mother and/or infant, HIV testing, and adherence counseling.

Clinical Study Identifier: NCT02778204

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Recruitment Status: Open


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