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Sponsors and Collaborators: |
Oswaldo Cruz Foundation Abbott |
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Information provided by: | Oswaldo Cruz Foundation |
ClinicalTrials.gov Identifier: | NCT00771498 |
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:
Condition | Intervention | Phase |
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HIV Infection Tuberculosis |
Drug: Rifampin |
Phase IV |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 30 |
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) |
Arms | Assigned Interventions |
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I
Patients with HIV/TB co-infection will receive treatment for both infection, and PK of lopinavir/r will be evaluated
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Drug: Rifampin
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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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patient has a previous history of hypersensitivity or known resistance or acquired to rifampin or to lopinavir-ritonavir.
2. Evidence of toxic substances abuse, such as alcohol and/or illicit drugs (Attachment B).
Contact: Valeria C Rolla, PhD | 55 21 | valeria.rolla@ipec.fiocruz.br |
Brazil, ES | |
University of Espirito Santo | |
Vitoria, ES, Brazil | |
Brazil, RJ | |
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 |
Responsible Party: | Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Oswaldo Cruz Foundation ( Valeria Cavalcante Rolla ) |
Study ID Numbers: | A06-295 |
Study First Received: | October 10, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00771498 |
Health Authority: | Brazil: National Committee of Ethics in Research |
rifampin lopinavir drug interaction pharmacokinetic |
Bacterial Infections Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Rifampin Gram-Positive Bacterial Infections |
Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection Antiviral Agents Actinomycetales Infections |
Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents Nucleic Acid Synthesis Inhibitors Leprostatic Agents |