Actively Recruiting
A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1
Led by ViiV Healthcare · Updated on 2026-05-19
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) the drug cabotegravir in newborn babies exposed to HIV-1. This Phase 1/2 study focuses on neonates up to 10 days old who have been exposed to HIV-1 and whose mothers are on dolutegravir-based treatment. The study aims to gather important data on cabotegravir use in this vulnerable population to better understand its effects and safety. Participants are divided into four groups receiving different dosing regimens of cabotegravir. Some receive a single oral dose on Day 1, while others receive multiple oral doses with dosing frequency determined as the study progresses. Another group receives a single intramuscular (IM) dose of long-acting cabotegravir (CAB LA) on Day 1, and another group receives multiple IM doses. The doses and frequency for repeat dosing are adjusted based on emerging data from earlier groups. During the study, researchers will monitor drug levels in the blood at various time points up to several months, assess adverse events including injection site reactions, and evaluate safety through laboratory tests and physical exams. Mothers and infants will be followed closely for up to two months after the last dose. The main outcomes include measuring maximum drug concentrations and tracking any side effects or serious events. This comprehensive monitoring aims to ensure participant safety and gather critical information on cabotegravir use in neonates.
CONDITIONS
Brief Title
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baby is at least 37 weeks gestation at delivery
- Baby is 10 days old or younger
- Baby has a birth weight of at least 2 kg
- Baby has started standard antiretroviral drug prophylaxis
- Baby is generally healthy as determined by medical evaluation
- Mother has been on dolutegravir-based HIV treatment for at least 4 weeks before delivery
- Mother is currently breastfeeding or plans to breastfeed
- Mother is legally able and willing to provide informed consent for herself and the baby
- Mother has confirmed HIV-1 infection based on positive test results from two separate blood samples
You will not qualify if you...
- Severe congenital malformation or medical condition incompatible with life or study participation
- Known maternal-fetal blood group incompatibility causing newborn hemolytic disease
- Known family history of G6PD deficiency
- Mother has received or will receive cabotegravir postpartum
- Baby or mother is receiving any disallowed medication
- Baby has exposure to other investigational drugs that may affect study drug metabolism
- Mother has known resistance to integrase strand transfer inhibitors
- Baby has confirmed positive HIV nucleic acid test
- Baby has abnormal lab results at screening including elevated liver enzymes, bilirubin requiring phototherapy, low hemoglobin, low white blood cells, low platelets, high creatinine, low albumin, or high direct bilirubin
- Any other Grade 3 or higher adverse event
- Baby has had prior exchange transfusion
- Mother or baby has any condition making study participation unsafe or interfering with study goals
- Baby is receiving dolutegravir as part of HIV prophylaxis
- Mother has known hepatitis B infection
- Baby has prolonged QT interval over 450 msec corrected by Fridericia's formula
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months depending on cohort and dosing schedule
Participants receive oral or intramuscular cabotegravir doses according to their assigned cohort starting on study Day 1. Dose and frequency depend on cohort and emerging data.
Multiple visits for drug administration and monitoring during treatment period
Duration - Up to 2 months post last dose
Participants are monitored for safety, tolerability, and pharmacokinetics for up to 2 months after the last dose administration.
Multiple visits for safety and blood sample collection during follow-up
Trial Site Locations
Total: 1 location
1
GSK Investigational Site
Parow Valley, South Africa, 7505
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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