Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • DTG 50 mg OD with food

    Drug

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

  • DTG 50 mg BID

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: DTG 50 mg OD with foodActive comparator 1 intervention
Group B: DTG 50 mg BIDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

proportion of subjects from the ITT analysis population with plasma HIV-1 RNA <50 c/mL at Week 24

The primary efficacy endpoint is the proportion of subjects from the ITT analysis population with plasma HIV-1 RNA \<50 c/mL at Week 24.

Time frame
Week 24

Secondary outcomes

1

AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Time frame
Week 4
2

Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Time frame
Week 4
3

Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Time frame
Week 4
4

Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

Time frame
Week 4

Other outcomes

Sponsors and contacts

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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
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