An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
This is a pharmacokinetic, descriptive, open-label, prospective, multicentric, national study
in Aids and tuberculosis co-infected patients, to be laboratory and clinically monitored
during the treatment with lopinavir-ritonavir and rifampin medications.
Study population: Thirty patients older than 18 years, both male and female, which present
active tuberculosis and failure or contraindication for any motive to an efavirenz will be
selected to participate in the study.
Objectives:
- Evaluate the pharmacokinetics of lopinavir-800mg / ritonavir-200mg combination (every 12
h) in association with rifampin-containing anti-tuberculosis regimens, in patients
presenting tuberculosis and HIV-infected with indication to antiretroviral treatment
according to Brazilian Ministry of Health's guidelines, with contraindication to the use
of NNTRI.
- Describe the adverse events observed during the tuberculosis treatment period with
rifampin associated with antiretroviral therapy consisting of lopinavir-800mg /
ritonavir-200mg every 12 hours.
- Describe clinical, immunological and virological endpoints throughout the study with
these drugs.