PETITE-3TC Study: Lamivudine Dosing in Preterm Infants

Open label, single-arm, single-center trial to evaluate the pharmacokinetics and safety of a model-based dose of lamivudine in preterm infants exposed to HIV (PETITE-3TC Study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605762717777

Enrollment

Registered

2026-05-29

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Paediatrics

Interventions

Lamivudine oral solution 10mg per mL Adcock Ingram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hospitalized preterm infant (<37 weeks' gestational age) born to a woman with HIV Receiving standard of care infant ARV prophylaxis Birth weight =1000 g Postnatal age of <28 days Negative birth HIV NAT test

Exclusion criteria

Exclusion criteria: Haemoglobin of 1.3 X upper limit of normal (ULN). Alanine Transaminase (ALT) and Aspartate Transaminase (AST) > 2.5 X ULN Not tolerating oral feeds Enrolment in another clinical trial Severe congenital anomalies or life-threatening disease

Design outcomes

Primary

Measure	Time frame
Will the proposed 3TC dosing strategy achieve therapeutic concentrations in preterm infants born to women with HIV, 3TC 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
safety of TC in the premature population- Occurrence of any adverse events (AEs) of Grade 3 or higher; or any treatment-related AE	—

Countries

South Africa

Contacts

Public ContactRobin Makoma

neonatology Fellow Stellenbosch University

robinm@sun.ac.za+27837134803

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026