PharmacokinEtic and safeTy of the 4-In-1 granules in neonaTEs: PETITE Study

Phase 1

Recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR202007806554538
• Lead Sponsor: Stellenbosch University Tygerberg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Written informed consent to participate in the study must be obtained for all participants from the parent(s) or legal guardian.
In addition, for each cohort, the following Cohort Specific Inclusion Criteria must be met at Study Entry:
Cohort 1A
•HIV-exposed neonates (pending HIV status) on standard of care ARV prophylaxis, as per local guidelines
•< 14 days of age
•Birth weight of =2500 g to ?4000 g
Cohort 1B
•HIV-exposed neonates (pending HIV status) on standard of care ARV prophylaxis, as per local guidelines
•= 3 days of age
•Birth weight of =2000 to ?4000 g
Cohort 2
•HIV-exposed neonates (pending HIV status) who are at high risk of perinatal HIV transmission on standard of care ARV prophylaxis, as per local guidelines
•= 3 days of age
•Birth weight of =2000 to ?4000 g

Exclusion Criteria

The presence of any of the following at entry, will exclude a subject from study enrolment:
•Less than 37 weeks gestational age at birth
•Baseline ECG has a QTc of > 0.45 sec
•Haemoglobin value of < 13.0 g/dL
•Hypokalemia (<3.6 mmol/L)
•Hyperkalemia (>6.7 mmol/L)
•Hyponatremia (<135 mmol/L)
•Hypernatremia (>145 mmol/L)
•A Creatinine value above the upper limit of normal for gestational age and postnatal age.
•AST or ALT of more than 1.25 the upper limit of normal (ULN)
•Total Bilirubin close to exchange value (based on local guidelines) or a high Bilirubin with red cell haemolysis
•Any other Grade =3 event on the DAIDS toxicity table
•Severe congenital abnormalities at investigator’s discretion
•Receiving treatment for tuberculosis (TB)
•Mothers on LPV-containing ARV treatment
•Any medications known to induce QT interval prolongation
•Critically ill infants at the discretion of the examining clinician
•Participation in another clinical trial
•HIV-infected neonates
•Neonatal abstinence syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified