Pharmacokinetics and Safety of DolutegravIr in Neonate

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Desmond Tutu TB Centre
• Collaborators: Chiang Mai University; UNITAID; University of Stellenbosch
• Treatments: Dolutegravir

Criteria

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