A Phase 2 interventional study of rifabutin in combination with efavirenz and rifabutin in combination with nevirapine in HIV Infections and Tuberculosis, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 1 site in South Africa. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-20.
Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Phase 2, Interventional, and Treatment
The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs.
This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.
Patients will be offered to participated in the study after the first 6 weeks of the nationally recommended TB treatment. All the enrolled patients will be switched to rifabutin and randomized, two weeks later, to one of the three study ARV regimens. The RBT doses will be then adapted to the allocated ARV regimen according to a cross over scheme. Three full pharmacokinetics profile will be performed at different time point : before initiation of ARV, after one month of the first RFB dosage and one month after the second RFB dosage.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 48 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 86 studies on the registry; none are open to participants now.
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Exclusion Criteria:
RBT associated with EFV based ART
Drug: rifabutin in combination with efavirenz
RBT associated with NVP based ART
Drug: rifabutin in combination with nevirapine
RBT associated with LPV/r based ART
Drug: rifabutin in combination with lopinavir/ritonavir
Ia. arm 1a: D4T/3TC/EFV(600mg)+INH/Rifabutin(450 mg OD 4 wks switch to 600 mg OD 4 wks); Ib. arm 1b: D4T/3TC/EFV(600mg)+INH/Rifabutin(600 mg OD 4 wks switch to 450 mg OD 4 wks);
IIa. arm 2a: D4T/3TC/NVP(200mg)+INH/Rifabutin(300 mg OD 4 wks switch to 450 mg OD 4 wks); IIb. arm 2b : D4T/3TC/NVP(200mg)+INH/Rifabutin(450 mg OD 4 wks switch to 300 mg OD 4 wks);
IIIa. arm 3a : D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg TPW 4 wks switch to 150 mg OD 4 wks); IIIb. arm 3b: D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg OD 4 wks switch to 150 mg TPW 4 wks).
Area under the curve (AUC) of rifabutine measured (a)before introduction of ART;(b)after ART initiation (two different doses of RBT in combination with efavirenz, nevirapine or lopinavir/ritonavir)
Time frame: 2, 6 and 10 weeks after randomisation
Area under the curve (AUC) of efavirenz, nevirapine and lopinavir/ritonavir in combination with two doses of rifabutine
Time frame: 6 and 10 weeks after randomisation
Safety : proportion of patients with grade 3 and grade 4 adverse events
Time frame: through out the trial
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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French National Agency for Research on AIDS and Viral Hepatitis