MedTrace Logo

Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

NCT04746547 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-01

No results posted yet for this study

Summary

Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF.

Note: An amendment has been added to include children from 3kgs and a dose of 10mg dispersible DTG

Conditions

Interventions

DRUG

Dolutegravir 50 MG

Twice daily dolutegravir with rifampicin containing TB treatment

DRUG

Dolutegravir 10 MG

Twice daily dolutegravir with rifampicin containing TB treatment

Sponsors & Collaborators

  • Centre for the AIDS Programme of Research in South Africa

    collaborator NETWORK

  • University of KwaZulu

    lead OTHER

Principal Investigators

  • Moherndran Archary, MBChB, PhD · University of KwaZulu

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2025-07-31
Completion
2025-07-31

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 NCT04746547 on ClinicalTrials.gov