Pharmacokinetic Study of Super-boosted Lopinavir/Ritonavir Given With Rifampin
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|ClinicalTrials.gov Identifier: NCT01700790|
Recruitment Status : Recruiting
First Posted : October 4, 2012
Last Update Posted : November 7, 2017
|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)|
|Estimated Enrollment :||12 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|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700790
|Contact: Catherine V Boulanger, M.D.||305 243 firstname.lastname@example.org|
|Contact: Valeria Calvacanti Rolla, M.D.||55 21 email@example.com|
|Instituto Nacional de Infectologia Evandro Chagas - Fiocruz(INI), Laboratorio de Pesquisa Clinica em Micobacterioses(LAPCLINTB)||Recruiting|
|Rio de Janeiro, RJ, Brazil, 21040-900|
|Contact: Valeria Calvacanti Rolla, MD 55 21 38659601 firstname.lastname@example.org|
|Contact: Isabella Campos Vargas de Morais, BSc, MSc 55 21 981090208 Isabella Moraes <email@example.com>|
|Principal Investigator: Valeria Calvacanti Rolla, M.D.|
|Principal Investigator:||Catherine Boulanger, MD.||University of Miami Miller Medical School of Medicine|
|Principal Investigator:||Valeria Calvicanti Rolla, MD||Oswaldo Cruz Foundation|