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An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin

NCT00771498 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-05-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lopinavir

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Valeria C Rolla, PhD · Oswaldo Cruz Foundation

  • Valeria C Rolla, PhD · Oswaldo Cruz Foundation

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771498 on ClinicalTrials.gov