An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin (A06-295)
Recruitment status was Recruiting
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.
- 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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Evaluation of the Pharmacological Interaction of Lopinavir 800mg - Ritonavir 200mg Combination and Rifampin in Subjects Presenting Tuberculosis, With Contraindication for Antiretroviral Regimens Including Efavirenz|
- Plasma levels of rifampin and lopinavir-ritonavir (pharmacokinetics). [ Time Frame: 15, 45 and 180 days post-study treatment start ] [ Designated as safety issue: No ]
- HIV response to treatment [ Time Frame: 90 and 180 days post-study treatment start ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Each study visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||February 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Patients with HIV/TB co-infection will receive treatment for both infection, and PK of lopinavir/r will be evaluated
ARV treatment: 2 NRTIs + lopinavir/r 800mg / 200 mg (4 tablets of Kaletra) every 12 hours, daily and orally Antituberculosis treatment: rifampin (600 mg/daily) + isoniazide (400 mg/daily) for 6 months, both in fasting condition + pirazinamide (2000 mg) for the first two months
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00771498
|Contact: Valeria C Rolla, PhD||55 firstname.lastname@example.org|
|University of Espirito Santo||Recruiting|
|Vitoria, ES, Brazil|
|Principal Investigator: David J Haddad, PhD|
|Sub-Investigator: Reynaldo Dietze, PhD|
|Sub-Investigator: Rodrigo R Rodrigues, PhD|
|Sub-Investigator: Moyses Palaci, PhD|
|Instituto de Pesquisa Clinica Evandro Chagas (IPEC)||Recruiting|
|Rio de Janeiro, RJ, Brazil|
|Principal Investigator: Valeria C Rolla, PhD|
|Sub-Investigator: Marly Jane M Costa, PhD|
|Sub-Investigator: Eduardo W Barroso, PhD|
|Sub-Investigator: Maria Cristina S Lourenço, MSc|
|Sub-Investigator: Luciane Velasque, MSc|
|Instituto Oswaldo Cruz (IOC)||Not yet recruiting|
|Rio de Janeiro, RJ, Brazil|
|Sub-Investigator: Mariza G Morgado, PhD|
|Principal Investigator:||Valeria C Rolla, PhD||Oswaldo Cruz Foundation|
|Study Chair:||Valeria C Rolla, PhD||Oswaldo Cruz Foundation|