A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorViiV Healthcare
About this trial
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 37 weeks gestation at delivery.
<=10 days of life.
Birth weight at least 2 kg.
At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis.
Disqualifiers
Severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by examining clinician.
Known maternal-fetal blood group incompatibility which can result in hemolytic disease of the newborn.
Known family history of G6PD deficiency.
Prior/Concomitant therapy
Trial design
Design model
Sequential
Treatments tested in this trial
Oral CAB
DrugCAB administered once orally on study Day 1 to the Stage 1: Single Oral Dose CAB (Cohort 1) and multiple times to the Stage 1: Multiple Oral Dose CAB (Cohort 2) group. Dose and dosing frequency for Cohort 2 to be determined based on emerging data from Cohort 1.
IM CAB LA
DrugCAB LA administered once intramuscularly on study Day 1 to the Stage 2: Single IM Dose CAB LA (Cohort 3) group and multiple times to the Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, into the in the anterolateral thigh muscle of participants. Dose for Cohort 3 to be determined based on emerging data from Cohort 2. Dose and dosing frequency for Cohort 4 to be determined based on emerging data from Cohort 3.
Treatment groups
44 Participants
are divided into 4 treatment groupsGroup A: Stage 1: Single Oral Dose CAB (Cohort 1) groupExperimental treatment 1 intervention
Group B: Stage 1: Multiple Oral Dose CAB (Cohort 2) groupExperimental treatment 1 intervention
Group C: Stage 2: Single IM Dose CAB LA (Cohort 3) groupExperimental treatment 1 intervention
Group D: Stage 2: Multiple IM Dose CAB LA (Cohort 4) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum observed plasma concentration (Cmax) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Blood samples are collected at specific time points for PK analysis to determine Cmax.
Time frame
At study Days 1, 3, 8, 15 and 222
Maximum observed plasma concentration (Cmax) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Blood samples are collected at specific time points for PK analysis to determine Cmax.
Time frame
At study Days 1, 3, 9,16, 28 and 423
Last observed plasma concentration (Clast) of CAB in participants from Stage 1: Single Oral Dose CAB (Cohort 1) group
Blood samples are collected at specific time points for PK analysis to determine Clast.
Time frame
At study Days 1, 3, 8, 15 and 224
Last observed plasma concentration (Clast) of CAB LA in participants from Stage 2: Single IM Dose CAB LA (Cohort 3) group
Blood samples are collected at specific time points for PK analysis to determine Clast.
Time frame
At study Days 1, 3, 9, 16, 28 and 42Secondary outcomes
1
Number of participants developing Grade 3 and higher AEs and SAEs, by severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in death. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Time frame
From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)2
Number of participants with Grade 3 and above bilirubin elevation.
The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
Time frame
From Day 1 up to 2-months post last dose administration (last dose administered at Day 1 to the single dose groups, at Month 1 to Stage 1: Multiple Oral Dose CAB (Cohort 2) group and at Month 6 to Stage 2: Multiple IM Dose CAB LA (Cohort 4) group)Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
GSK Investigational SiteRecruiting7505, Parow Valley
South Africa
South AfricaSponsors and contacts
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Source ClinicalTrials.gov