Efficacy, Safety and Pharmacokinetics of DTG with RIF
ConditionHIV/TB Coinfection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe HIV Netherlands Australia Thailand Research Collaboration
About this trial
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.
Eligibility criteria
Qualifiers
documented HIV positive
Aged >18 years
ARV naïve (previous exposure to ARV for < 2 weeks)
Any CD4 cell count
Disqualifiers
Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or INIs
Have previously treated for tuberculosis
Currently using immunosuppressive agents.
Currently using any prohibited medications that can affect the pharmacokinetics of the study drug such as phenobarbital, and carbamazepine
Trial design
Treatments tested in this trial
- DTG 50 mg OD with food
- DTG 50 mg BID
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Lead sponsor
Chulalongkorn University
Collaborator
Bamrasnaradura Infectious Diseases Institute
Collaborator
Bhumibol Adulyadej Hospital
Collaborator
Infectious Disease Taksin Hospital
Collaborator
Klang Hospital
Collaborator
Infectious Disease Chiangrai Prachanukroh Hospital
Collaborator
Infectious Disease Chonburi Hospital
Collaborator
Infectious Disease Buddhachinaraj Phitsanulok Hospital
Collaborator
Radboud University Medical Center
Collaborator
Ministry of Health, Thailand
Collaborator
Source ClinicalTrials.gov