Pharmacokinetics and Safety of DolutegravIr in Neonate
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose
PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates
born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are
on ARV postnatal prophylaxis will be enrolled.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Desmond Tutu TB Centre
Collaborators:
Chiang Mai University UNITAID University of Stellenbosch