Open Label, Single Arm, Two-stage Trial to Evaluate the Single and Multi-dose Pharmacokinetics and Safety of the Paediatric Dolutegravir (10 mg, Scored) Dispersible Tablet in HIV-exposed Neonates

2019-36-SUN-MDR

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.

2022-09-12

2024-06-30

2024-12-31

Recruiting

Early phase I

56

Inclusion Criteria: * Stage 1: Inclusion Criteria * HIV-exposed neonate (pending HIV status) born to a woman within HIV on DTG-based ART * Birth weight of ≥2000 g and on standard of care ARV prophylaxis Cohort Specific Inclusion Criteria in Stage 1 must be met at Study Entry: Cohort 1A: Infant \<14 days of life Cohort 1B: Infant ≤3 days of life Stage 2: Inclusion Criteria * Low risk\* HIV-exposed neonate (pending HIV status) born to a virologically suppressed woman on DTG-based ART \*Neonate born to a woman with a documented plasma HIV-1 RNA result \<50 copies/mL in the 4 weeks prior to delivery or between delivery and infant study entry * Birth weight of ≥2000 g and on standard of care ARV prophylaxis Cohort Specific Inclusion Criteria in Stage 2 must be met at Study Entry: Cohort 2: Infant \<7 days of life Exclusion Criteria: * • Less than 37 weeks gestational age at birth * Known blood group incompatibilities which can result in hemolytic disease of the newborn (e.g., Rh-negative mother, presence of antibodies on neonatal red blood cells, etc.) * Total bilirubin values approaching an exchange transfusion as defined by local guidelines (Section 18.2) * Haemoglobin value of \<13.0 g/dL * Platelet count of less than 50,000 cells/mm3) * Decreased total white blood cell count (Grade 3 and above) * Creatinine value more than 1.3 the upper limit of normal (ULN) for gestational age and postnatal age (Grade 2 and above) * AST or ALT of more than 2.5 the ULN (Grade 2 and above) * Any other current Grade ≥3 event on the DAIDS toxicity table * Severe congenital abnormalities or critically ill neonates at discretion of the examining clinician * Receiving medicine(s) that can impact DTG pharmacokinetics (Section 8.7) * Participation in another clinical trial * HIV-infected neonates

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase I/II, open-label, single arm, two-stage pharmacokinetic and safety study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}

2023-12-18