Pharmacokinetic Study of Super-boosted Lopinavir/Ritonavir Given With Rifampin
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|ClinicalTrials.gov Identifier: NCT01700790|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|AIDS Tuberculosis||Drug: Lopinavir/ritonavir and ritonavir||Phase 4|
This will be an open label non-randomized pharmacokinetic study of 10-12 HIV-infected patients co-infected with Mycobacterium tuberculosis.
Enrollment: Potential subjects with active tuberculosis who have tolerated a rifampin containing regimen for at least 2 weeks. Potential subjects will be referred from the surrounding communities to Laboratorio de Pesquisa Clinica em Micobacterioses(LAPCLINTB)
Visit 1: Subjects will then be started on lopinavir/ritonavir containing HAART regimen with standard twice daily dosing. Ritonavir 100 mg capsules will be added to the regimen and the dose escalated until the patient is taking 3 capsules twice daily. The time between enrollment and visit 1 will be determined by the treating physician.
Visit 2: They will return about 1 week after dose escalation has been completed to sample lopinavir and rifampin concentrations.
Visit 3: Subject will return in 2 weeks to have repeat to review results of lopinavir concentrations and response to therapy. Ritonavir will be adjusted as needed.
Visit 4: Subject will then return in 4 weeks for last visit for evaluation. Lopinavir and rifampin PK will be done.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacokinetic Study of Super-boosted Lopinavir/Ritonavir in Combination With Rifampin in HIV-1-infected Patients With Tuberculosis.|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 17, 2018|
|Estimated Study Completion Date :||May 2019|
Experimental: Lopinavir/ritonavir and ritonavir
Two tablets of twice daily of Lopinavir/ritonavir 200 mg/50mg with 3 tablets of ritonavir 100 mg of twice daily given with rifampin 600 mg daily.
Drug: Lopinavir/ritonavir and ritonavir
Two tablets twice daily of Lopinavir/ritonavir 200 mg/50mg with 3 capsules of ritonavir 100 mg twice daily given with rifampin 600 mg daily
- Proportion of patients with expected pre dose concentration of lopinavir. [ Time Frame: Weeks 2 and 8: lopinavir time points at hours 0, 2, 4, 6 and 8. ]The expected pre dose concentration of lopinavir is >1.0 mcg/mL.
- Proportion of patients with successful treatment of HIV therapy. [ Time Frame: Approximately 10-12 weeks ]HIV failure will be defined as failure to drop the viral load by 0.5 log 10 copies/mL drop by week 4 of treatment and a viral load drop >1 log 10 copies/ml by week 8.
- Proportion of patients with expected AUC of rifampin [ Time Frame: Approximatley 10-12 weeks ]The expected AUC of rifampin is 44-70 mcg•h/mL
- Proportion of patient with success of tuberculosis therapy [ Time Frame: Approximatly 10-12 weeks ]Success of treatment using criteria established by the Brazilian National Ttuberculosis Program.
- Proportion of patients with expected Cmax and AUC of lopinavir [ Time Frame: 10-12 weeks ]The expected Cmax of lopinavir is 6-14 mcg/mL. The expected AUC lopinavir is 56-130 µg•h/mL
- Proportion of patients with expected Cmax of rifampin. [ Time Frame: Weeks 2 and 8: rifampin time points at hours 0, 2, 4, 6 and 8. ]Expected maximum concentration of rifampin is 8-24 mcg/mL
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): NCT01700790
|Instituto Nacional de Infectologia Evandro Chagas - Fiocruz(INI), Laboratorio de Pesquisa Clinica em Micobacterioses(LAPCLINTB)|
|Rio de Janeiro, RJ, Brazil, 21040-900|
|Principal Investigator:||Catherine Boulanger, MD.||University of Miami Miller Medical School of Medicine|
|Principal Investigator:||Valeria Calvicanti Rolla, MD||Oswaldo Cruz Foundation|