NCT00771498: A06-295

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

Completed Phase 4 Last updated 15 May 2015

What this trial tests

Phase 4 trial testing Lopinavir in HIV Infection in 30 participants. Completed in 1 December 2012.

Timeline

1 November 2008

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Oswaldo Cruz Foundation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Enrollment	30
Start date	1 November 2008
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	3 locations across Brazil

Drugs / interventions tested

• Lopinavir (LOPINAVIR) — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →
• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Oswaldo Cruz Foundation

Who can join

18 and older, any sex, with HIV Infection or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Plasma levels of rifampin and lopinavir-ritonavir (pharmacokinetics).
  Time frame: 15, 45 and 180 days post-study treatment start

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. TB and HIV Therapeutics: Pharmacology Research Priorities.
   Dooley KE, Kim PS, Williams SD, Hafner R. · · 2012 · cited 14× · PMID 22829999 · DOI 10.1155/2012/874083