The Union's phase II pharmacokinetic (PK) study assessing different doses of rifabutin in combination with protease inhibitor-based antiretroviral therapy (ART) for HIV-infected patients with tuberculosis in Ho Chi Minh City, Viet Nam (ANRS 12150b Trial) has been completed. The study not only produced useful data but also resulted in other benefits.
The goal of the study was to determine which of two doses of rifabutin (150 mg three times a week or 150 mg daily) in 33 enrolled patients at Pham Ngoc Thach Hospital in Ho Chi Minh City, Vietnam, produced better pharmacokinetic profiles when used in combination with an ART regimen that included lopinavir/ ritonavir. The data showed that RBT at a dose of 150 mg once daily produced the best results. The complete set of results will be reported in a forthcoming paper.
An additional, but also important, outcome of this trial is that the team from the Pham Ngoc Thach Hospital Clinical Research Unit, who worked with The Union, received training in how to conduct clinical trials and have now been accredited by the Vietnamese Ministry of Health. This means they can participate in various clinical studies – and, in fact, they now are participating in The Union-MRC STREAM clinical trial, which is assessing the efficacy and safety of short-course treatment for multidrug-resistant TB.
The Union's PK trial was funded by the Agence Nationale de Recherche sur le Sida et les hépatites virales (ANRS) and Fondation Total. A sister study in South Africa was completed in August 2010.