||Senior Fellowship (SF)
Rifabutin with lopinavir/ritonavir in patients coinfected with tuberculosis
and HIV in Burkina Faso: Pilot study of pharmacokinetics to define the
minimum effective dose
To assess the pharmacokinetic profile of rifabutin (RFB) and its
active metabolite 25-O-desacetyl-rifabutin on the two dosing
regimens (RFB 150 mg or 300 mg 3 times a week) in TB-HIV
coinfected patients in Burkina Faso, a resources-limited country
with high prevalence of tuberculosis and HIV.
To determine the pharmacokinetics parameters of RFB in
combination with Lopinavir/ritonavir in Burkinabe HIV infected
patients with 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 in West Africa.
|Institut de Recherche en Sciences de la Santé
|Potiandi Serge Diagbouga
||University of Pavia
||University of Brescia
||Institut de Recherche en Sciences de la Santé
Phase II: Pharmacokinectics for dosing
Results & Outcomes
Capacity Building and networking:
The fellow and co-investigator attended several training courses over the
duration of the project to enhance their ability to develop and
implement a clinical trial. In addition, the co-investigator had an
opportunity to intern at the LBV in Aristide le Dantec University in
The fellow managed to develop collaborations with several research
institutions and a pharmaceutical company to assist with acquisition of
the investigational drugs, protocol development and skill transfer in the
field of drug interactions and clinical research.
In addition, the grantee managed to obtain funding to build and equip a
new biomedical laboratory.
This study aimed to assess the pharmacokinetic profile of two doses of
Rifabutin (150 mg and 300 mg every two days) associated with Lopinavir
/ Ritonavir in patients co-infected by TB and HIV. There was a delay
recruiting patients, due to a delay in the acquiring the study drugs and
obtaining study protocol and ethics approval from the national
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regulatory authority for clinical trials.
The target sample size was 30. Between May 2013 to December 2014, 91
patients co-infected by TB and HIV were screened, among these 11 were
included in the study. The 11 participants were randomly assigned to the
two treatment arms and followed up. Six patients in arm A (rifabutin 150
mg) and five patients in arm B (rifabutin 300 mg).
All patients enrolled have already undergone blood samplings for
pharmacokinetic tests and the participant recruitment was extended to
July 2015. The trial will be completed using funds from the home
Several publications are expected after the completion of data analysis.