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Pharmacokinetics and Safety of DolutegravIr in Neonate

NCT05590325 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dolutegravir

Single dose of the DTG-DT in two sequential cohorts and multiple-doses of the DTG-DT or DTG-ODF in a two cohorts. Qualitative Acceptability will be collected from mothers and health workers in structured discussion guides.

Sponsors & Collaborators

  • Chiang Mai University

    collaborator OTHER

  • UNITAID

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • Desmond Tutu TB Centre

    lead OTHER

Principal Investigators

  • Adrie Bekker, Prof · University of Stellenbosch

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590325 on ClinicalTrials.gov