To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients
The overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for the combined treatment of tuberculosis and HIV infection. Rifabutin represents an alternative to rifampicin for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated ART drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination with LPV/r regimens in Thai HIV/TB infected patients, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of rifabutin and rifampicin regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
200/50 mg tablet LPV/rtv
Chest Division, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, Thailand
Infectious Diseases, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand
pharmacokinetics of rifabutin Cmax
Cmax The peak plasma concentration of rifabutin after administration
Time frame: 48 weeks
adverse events
number of participants with adverse events
Time frame: 48 weeks
viral load
Time frame: 48 weeks
CD4
mean CD4 rise from baseline
Time frame: 48 weeks
Monodrug resistant TB
Time frame: 48 weeks
death
Time frame: 48 weeks
AIDS event
Time frame: 48 weeks
TB cure
Time frame: 48 weeks
TB relapse
Time frame: 48 weeks
Multidrug-resistant TB (MDR TB)
Time frame: 48 weeks
TB treatment failure
Time frame: 48 weeks
Extensively drug resistant TB (XDR TB)
Time frame: 48 weeks
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weight gain
change from baseline in weight gain at 48 weeks
Time frame: 48 weeks
defervescence
change from baseline in defervescence at 48 weeks
Time frame: 48 weeks
Karnofsky score
change from baseline in Karnofsky score at 48 weeks
Time frame: 48 weeks