Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants
Source: ClinicalTrials.gov NCT01828073 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PK Parameter: Neonatal RAL Elimination Half-life (T1/2) |
26.6; 24.4 | — |
| PRIMARY Ratio of Cord Blood to Maternal Blood RAL Concentrations |
1.48; 2.62 | — |
| PRIMARY Number of Infants Who Met Composite Safety Endpoint (Grade 3/4 Adverse Event, Adverse Birth Outcome, Death) |
7; 9 | — |
| PRIMARY Infant Total Bilirubin |
3.7; 6.6; 5.7; 10.7; 2.7; 4.6 | — |
| PRIMARY Infant Direct Bilirubin |
0.3; 0.5; 0.4; 0.4; 0.3; 0.5 | — |
| PRIMARY Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice |
0; 0; 1; 4; 0; 0 | — |
| SECONDARY Neonatal RAL Elimination (T1/2) by UGT1A1 Genotype Group (Normal VS Mutation) |
40.85; 32.75; 21.1; 39.7 | 0.747 |
Eligibility Criteria
Participant study inclusions and exclusion criteria are listed below.
Cohort 1 M-I pairs were enrolled prior to delivery so that only maternal study inclusion and exclusion criteria were assessed at enrollment.
Cohort 1: Maternal Study Inclusion Criteria
- Documentation of HIV-1 infection.
- Viable singleton pregnancy with gestational age of at least 35 weeks based on clinical or other obstetrical measurements with normal fetal anatomy
- Currently receiving RAL 400 mg twice daily for at least 2 weeks prior to enrollment in combination with other ARV agents for clinical care
- Plan to continue taking RAL in combination with other ARV agents through labor prior to delivery
- Willing and intends to deliver at the study-affiliated clinic or hospital
- Willing and able to sign informed consent for participation of herself and her infant. Participant must be of an age to provide legal informed consent as defined by the country in which she resides. If not, informed consent must be signed by a legal guardian.
Cohort 1: Maternal Study Exclusion Criteria
- Receipt of disallowed medications (phenobarbital, phenytoin, rifampin) within 4 weeks prior to enrollment
Cohort 1 Infants were enrolled prior to delivery so there were no infant study inclusion/exclusion criteria. However, only infants who met the following criteria were eligible for PK blood sampling. Infants ineligible for PK sampling remained in the study and were followed-up for safety.
Cohort 1: Infant PK Sampling Inclusion Criteria
- Infant born to women who received at least 2 weeks of RAL prior to delivery and continue to receive RAL during labor prior to delivery in addition to their other ARV drugs
- Infant birth weight of at least 2 kg
- Infant at least 37 weeks gestation at delivery
- Infant not receiving disallowed medications (phenobarbital, phenytoin, rifampin). If these medications are required for the infant's care, the infant will be ineligible for further PK sampling. PK samples will be obtained up to the time of the introduction of the disallowed medication.
Cohort 1: Infant PK Sampling Exclusion Criteria
- Infant has a severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the examining clinician
Cohort 2 enrolled M-I pairs at two time points: prior to delivery and within 48 hours after delivery.
- For M-I pairs enrolled prior to delivery, the maternal study eligibility criteria were assessed at enrollment. There were no infant study eligibility criteria. However, only infants who met the PK sampling eligibility criteria had PK blood sampling. Infants ineligible for PK sampling remained in the study and were followed-up for safety.
- For M-I pairs enrolled within 48 hours delivery, the maternal and infant study eligibility criteria were assessed at enrollment. A M-I pair was enrolled only if both the mother and the infant were eligible for the study. For multiple births, only infants who met the study eligibility criteria were enrolled.
Cohort 2: Maternal Study Inclusion Criteria: M-I pairs enrolled prior to delivery
- Documentation of HIV-1 infection.
- Viable singleton or multiple birth pregnancy based on clinical or other obstetrical measurements with infant birth weight anticipated to be less than or equal to 2,500 grams
- RAL is currently used as part of maternal ARV regimen and planned to continue through labor and delivery
- Willing and intends to deliver at the study-affiliated clinic or hospital
- Willing and able to sign informed consent for participation of herself and her infant. Participant must be of an age to provide legal informed consent as defined by the country in which she resides. If not, informed consent must be signed by a legal guardian.
Cohort 2: Maternal Study Exclusion Criteria: M-I pairs enrolled prior to delivery
- Receipt of disallowed medications (phenobarbital, phenytoin, rifampin) within 4 weeks prior to en
Data sourced from ClinicalTrials.gov (NCT01828073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.