HIV/AIDS
Conditions
Interventions
Quadrimune.
Quadrimune
Sponsors
Stellenbosch University Tygerberg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 6.7 mmol/L) • Hyponatremia (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Occurrence of the following events: adverse events of Grade 3 or higher; treatment-related adverse events of Grade 3 or higher; any adverse events •ABC, 3TC, LPV plasma pharmacokinetics parameters: area under the concentration time curve (AUC); maximum plasma concentration (Cmax), apparent clearance (CL/F), and trough concentration (Ctrough) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Acceptability to caregivers and neonates of using Quadrimune will be measured by means of a questionnaire | — |
Countries
South Africa
Contacts
Public ContactAdrie Bekker
Principal Investigator
Outcome results
None listed