An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin (A06-295)
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|ClinicalTrials.gov Identifier: NCT00771498|
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : May 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Tuberculosis||Drug: Lopinavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Patients with HIV/TB co-infection will receive treatment for both infection, and PK of lopinavir 800mg + ritonavir 200mg (PO BID) during 5 months will be performed
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
Other Name: Kaletra
- Plasma levels of rifampin and lopinavir-ritonavir (pharmacokinetics). [ Time Frame: 15, 45 and 180 days post-study treatment start ]
- HIV response to treatment [ Time Frame: 90 and 180 days post-study treatment start ]
- Adverse events [ Time Frame: Each study visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771498
|University of Espirito Santo|
|Vitoria, ES, Brazil|
|Instituto de Pesquisa Clinica Evandro Chagas (IPEC)|
|Rio de Janeiro, RJ, Brazil|
|Instituto Oswaldo Cruz (IOC)|
|Rio de Janeiro, RJ, Brazil|
|Principal Investigator:||Valeria C Rolla, PhD||Oswaldo Cruz Foundation|
|Study Chair:||Valeria C Rolla, PhD||Oswaldo Cruz Foundation|