A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
CABNATE
A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1
1 other identifier
interventional
66
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Mar 2026
Typical duration for phase_1 hiv-infections
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2025
CompletedFirst Posted
Study publicly available on registry
December 10, 2025
CompletedStudy Start
First participant enrolled
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 10, 2029
December 10, 2025
November 1, 2025
3.6 years
November 27, 2025
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
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.
At study Days 1, 3, 8, 15 and 22
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.
At study Days 1, 3, 9,16, 28 and 42
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.
At study Days 1, 3, 8, 15 and 22
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.
At study Days 1, 3, 9, 16, 28 and 42
Area under the curve time 0 to the last time point (AUC0-t) 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 AUC0-t.
At study Days 1, 3, 8, 15 and 22
Area under the curve time 0 to the last time point (AUC0-t) 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 AUC0-t.
At study Days 1, 3, 9, 16, 28 and 42
Pre-dose concentrations (C0h) of CAB in participants from Stage 1: Multiple Oral Dose CAB (Cohort 2) group
Blood samples are collected at specific time points for PK analysis to determine C0h.
At Study Days 1, 3, 7, 14, 28, 35, 42 and 49
Pre-dose concentrations (C0h) of CAB LA in participants from Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
Blood samples are collected at specific time points for PK analysis to determine C0h.
At Study Days 1, 3, 7, 21, 28, 42, 56, 70, 84, 98, 112, 140 and 168
Post-dose concentrations of CAB in participants from Stage 1: Multiple Oral Dose CAB (Cohort 2) group
Blood samples are collected at specific time points for PK analysis to determine post-dose concentrations.
At Study Days 1, 3, 7, 14, 21, 28, 35, 42 and 49
Post-dose concentrations of CAB LA in participants from Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
Blood samples are collected at specific time points for PK analysis to determine post-dose concentrations.
At Study Days 1, 3, 7, 14, 21, 28, 35, 42, 56, 70, 84, 98, 112, 140 and 168
Number of participants with drug-related adverse event (AEs) by severity
A drug-related AE is any untoward medical occurrence in a clinical study participant considered related to the study intervention. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
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)
Number of participants with serious AEs (SAEs) by severity
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 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
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)
Number of participants with injection site reactions (ISRs) by severity
An ISR is defined as an adverse event which is localized at the injection site, typically includes pain, tenderness, erythema, redness, induration, swelling, nodules or pruritus, but may also encompass other reactions. The severity of events is graded using the DAIDS grading scale, where grades are defined based on numeric criteria as follows: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life-threatening. A higher grade indicates greater severity.
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)
Number of participants who discontinue the study intervention due to AEs or injection intolerability
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.
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)
Secondary Outcomes (2)
Number of participants developing Grade 3 and higher AEs and SAEs, by severity
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)
Number of participants with Grade 3 and above bilirubin elevation.
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)
Study Arms (4)
Stage 1: Single Oral Dose CAB (Cohort 1) group
EXPERIMENTALParticipants receive a single dose of oral CAB suspension on study Day 1.
Stage 1: Multiple Oral Dose CAB (Cohort 2) group
EXPERIMENTALParticipants receive repeat doses of oral CAB suspension starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 1.
Stage 2: Single IM Dose CAB LA (Cohort 3) group
EXPERIMENTALParticipants receive a single IM dose of CAB LA on study Day 1. Dose to be determined based on data from Cohort 2.
Stage 2: Multiple IM Dose CAB LA (Cohort 4) group
EXPERIMENTALParticipants receive repeat IM doses of CAB LA starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 3.
Interventions
CAB 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.
CAB 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.
Eligibility Criteria
You may qualify if:
- 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.
- At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings.
- Mother is on a Dolutegravir (DTG) based regimen for a minimum of 4 weeks prior to delivery, regardless of maternal viral load.
- Mother is currently breastfeeding or plans to breastfeed infant.
- Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide documented informed consent for her and her infant's participation in this study.
- Mother has confirmed HIV-1 infection based on positive test results from 2 samples collected from 2 separate blood samples. Test results may be obtained from medical records or from testing performed during the study Screening period.
You may not qualify if:
- Medical conditions
- 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
- Mother who has previously received, is receiving, or will be receiving CAB post-partum.
- Neonate or breastfeeding mother is receiving any disallowed medication.
- Prior/Concurrent clinical study participation
- Neonate has exposure to other investigational drugs that might interfere with study intervention metabolism.
- Diagnostic assessments
- Mother has known Integrase strand transfer inhibitor (InSTI) resistance.
- At Entry, neonate with a confirmed, documented positive HIV Nucleic acid amplification test (NAAT) test result.
- At Screening, neonate has any of the following laboratory test results:
- Alanine transaminase or Aspartate aminotransferase of more than 2.5 x Upper limit of normal (ULN).
- Total bilirubin in range for phototherapy at Entry.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Open-label study.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2025
First Posted
December 10, 2025
Study Start
March 17, 2026
Primary Completion (Estimated)
October 10, 2029
Study Completion (Estimated)
October 10, 2029
Last Updated
December 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf.