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
Qualifiers
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
Treatments tested in this trial
- Oral CAB
- IM CAB LA
Treatment groups
44 Participants
are divided into 4 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
GSK Investigational SiteRecruiting7505, Parow Valley
South Africa
South AfricaSponsors and collaborators
Source ClinicalTrials.gov