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RecruitingPhase 2NCT03731559

Efficacy, Safety and Pharmacokinetics of DTG with RIF

Efficacy, Safety and Pharmacokinetics of Dolutegravir 50 Mg Once Daily with Food Versus Dolutegravir 50 Mg Twice Daily in HIV/TB Co-infected Patients Receiving Rifampin-based Antituberculosis Therapy

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Enrollment

200 participants

Start Date

Jun 25, 2019

Study Type

INTERVENTIONAL

Conditions

HIV/TB Coinfection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • documented HIV positive
  • Aged \>18 years
  • ARV naïve (previous exposure to ARV for \< 2 weeks)
  • Any CD4 cell count
  • ALT \<5 times ULN
  • estimated GFR\>60 ml/min/1.73m2
  • Hemoglobin \>7 mg/L
  • TB is diagnosed and there is a plan to receive stable doses of RIF containing anti-TB therapy for at least another 4 week period after initiation of ART
  • No other active OI (CDC class C event) except oral candidiasis or disseminated MAC
  • Body weight \>40kg
  • Able to provide written informed consent

Exclusion Criteria10

  • 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
  • Currently using alcohol or illicit substances that may affect the conduct of the trial as per the opinion of the site Principal Investigator
  • Unlikely to be able to remain in the follow-up period as defined by the protocol
  • Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
  • Have Karnofsky performance score \<30%
  • Have TB meningitis, bone/joints (due to prolonged use of anti-TB drug)
  • Pregnant or breastfeeding

Interventions

DRUGDTG 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

DRUGDTG 50 mg BID

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

Locations(10)

Klang Hospital

Bangkok, Bangkok, Thailand

Bhumibol Adulyadej Hospital

Bangkok, Bangkok, Thailand

Infectious Disease, Chulalongkorn University

Bangkok, Bangkok, Thailand

Infectious Disease Taksin Hospital

Bangkok, Bangkok, Thailand

Infectious Disease Chonburi Hospital

Chon Buri, Changwat Chon Buri, Thailand

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, Thailand

Infectious Disease Buddhachinaraj Phitsanulok Hospital

Phitsanulok, Changwat Phitsanulok, Thailand

Infectious Disease Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, Thailand

Chest Division, Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

HIV-NAT, Thai Red Cross - AIDS Research Centre

Bangkok, Thailand

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NCT03731559