MedTrace Logo

Efficacy, Safety and Pharmacokinetics of DTG with RIF

NCT03731559 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-02

No results posted yet for this study

Summary

The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy. This Stage II trial will determine precisely the PK parameters of DTG in combination with RIF regimen in Thai HIV/TB co-infected patients. After the optimal dose of DTG has been found, it will be further tested in a larger Stage III trial to assess its safety, tolerability and efficacy when used with RIF based regimen.

Conditions

  • HIV/TB Coinfection

Interventions

DRUG

DTG 50 mg OD with food

Dolutegravir 50 mg once daily with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy

DRUG

DTG 50 mg BID

Dolutegravir 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.

Sponsors & Collaborators

  • Chest Division, Chulalongkorn University

    collaborator UNKNOWN

  • Infectious Disease, Chulalongkorn University

    collaborator UNKNOWN

  • Bamrasnaradura Infectious Diseases Institute

    collaborator OTHER_GOV

  • Bhumibol Adulyadej Hospital

    collaborator OTHER

  • Infectious Disease Taksin Hospital

    collaborator UNKNOWN

  • Klang Hospital

    collaborator UNKNOWN

  • Infectious Disease Chiangrai Prachanukroh Hospital

    collaborator UNKNOWN

  • Infectious Disease Chonburi Hospital

    collaborator UNKNOWN

  • Infectious Disease Buddhachinaraj Phitsanulok Hospital

    collaborator UNKNOWN

  • Radboud University Medical Center

    collaborator OTHER

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Anchalee Avihingsanon, MD, PhD · HIV-NAT, Thai Red Cross - AIDS Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Thailand

Study Locations

More Related Trials

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 NCT03731559 on ClinicalTrials.gov