Evaluating the Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Intervention: Maraviroc; Maraviroc
Intervention description: 8 mg/kg oral solution as a single dose.; 8 mg/kg oral solution given twice daily.
Intervention MeSH terms: Maraviroc
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Maximum age: 3 Days
Healthy volunteers: No
Keywords: Vertical HIV exposure; Neonates; Maraviroc

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

Eligibility criteria:

        Inclusion Criteria:

          -  Mother was of legal age to provide independent informed consent for research
             participation and was willing and able to provide written informed consent for her and
             her infant's participation in this study.

          -  Mother had confirmed HIV-1 infection based on testing of two samples collected at
             different time points. More information on this criterion can be found in the
             protocol.

          -  At entry, infant met EFV exposure requirements, based on mother's report and confirmed
             by medical records if available, as follows:

               -  For Cohort 1, Stratum 1A: Infant born to a mother who did not receive EFV during
                  the eight weeks immediately prior to delivery. Note: Breastfeeding and formula
                  feeding infants were eligible for this stratum.

               -  For Cohort 1, Stratum 1B: Infant born to a mother who received EFV for a minimum
                  of two weeks immediately prior to delivery. Note: Breastfeeding and formula
                  feeding infants were eligible for this stratum.

               -  For Cohort 2, Stratum 2A: Infants born to a mother who did not receive EFV during
                  the eight weeks immediately prior to delivery and if breastfeeding, mother was
                  not receiving maternal EFV. Note: Breastfeeding and formula feeding infants were
                  eligible for this stratum.

               -  For Cohort 2, Stratum 2B: Breastfeeding infants born to a mother who received EFV
                  for a minimum of two weeks immediately prior to delivery, intended to breastfeed
                  for a minimum of six weeks and continued to receive maternal EFV while
                  breastfeeding. Note: Only breastfeeding infants were eligible for this stratum.

          -  At birth, infant's estimated gestational age was at least 37 weeks. Note: If
             gestational age at birth is not documented in the infant's available birth records,
             study staff may assess gestational age at the earliest possible opportunity during the
             screening period and use this assessment for purposes of eligibility determination.

          -  At birth, infant's weight was at least 2 kg. Note: If weight at birth is not
             documented in the infant's available birth records, study staff may assess infant
             weight at the earliest possible opportunity during the screening period and use this
             assessment for purposes of eligibility determination.

          -  At entry, infant was less than or equal to 3 days old.

          -  At entry, infant had the following lab values:

               -  Grade 0 alanine transaminase (ALT) (normal)

               -  Less than or equal to Grade 1 aspartate aminotransferase (AST) and total
                  bilirubin

               -  Less than or equal to Grade 2 hemoglobin, white blood cell counts, platelet
                  counts

          -  At entry, infant had initiated antiretroviral prophylaxis that did not include a
             potent CYP3A4 inhibitor or inducer. See the protocol for more information.

          -  At entry, infant was assessed by the site investigator or designee as generally
             healthy based on review of available medical records, other available medical history
             information, and physical examination findings.

          -  Born after singleton delivery (not after multiple birth).

        Exclusion Criteria:

          -  Infant had any other condition that, in the opinion of the site investigator or
             designee, would make participation in the study unsafe, complicate interpretation of
             study outcome data, or otherwise interfere with achieving the study objectives; for
             example, severe congenital malformation, other medical condition, or clinically
             significant finding from physical examination.

          -  At entry, any positive infant HIV nucleic acid test result (results are not required
             to be available prior to entry but any positive results obtained prior to entry are
             exclusionary).

          -  At entry, infant or breastfeeding mother was receiving any disallowed medication
             listed in the protocol.

          -  Mother received maraviroc during pregnancy.