The pharmacokinetics of lopinavir in South African HIV-infected volunteers receiving rifampicin with adjusted doses of LOPINAVIR/ritonavir.

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201206000159453
• Date of registration: 14/08/2009
• Primary sponsor: UCT
• Public title: The pharmacokinetics of lopinavir in South African HIV-infected volunteers receiving rifampicin with adjusted doses of LOPINAVIR/ritonavir.
• Scientific title: The pharmacokinetics of lopinavir in South African HIV-infected volunteers receiving rifampicin with adjusted doses of LOPINAVIR/ritonavir.
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201206000159453
• Study type: interventional
• Study design: Single group: all participants receive same intervention throughout study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Eric Decloedt

• Name: Pete Smith

Key inclusion & exclusion criteria

Inclusion criteria: ? HIV-infected adults (b18 yr)
? Established on an antiretroviral regimen comprising LPV 400 mg/RTV 100 mg and 2 NRTIs b 6 months
? Undetectable viral load
? ALT normal
? Recent Hepatitis B virus surface antigen negative and HCV Ab negative
? Normal ECG at a screening visit
? Normal serum potassium at a screening visit
? Medically stable

Exclusion criteria: ? Previously failed to attain or maintain virological suppression on a protease inhibitor-containing regimen.
? Known to have chronic renal, hepatic or GIT disease that may interfere with the pharmacokinetics of the drugs studied.
? Known to have cardiac disease that may increase the risk for developing cardiac conduction abnormalities.
? ECG changes consistent with a prolonged PR interval (b0.20s) and QT prolongation as identified by using a QT correction formula. QT interval with Fridericia?s correction b 480 ms.
? Hypo or hyperkalaemia, a family history of Long QT syndrome or on medication that may prolong the QT/QTc interval.
? Fasting cholesterol b7.77 mmol/L, fasting triglyceride b 8.49 mmol/L or abnormal glucose measurements at baseline or 6 monthly checks.
? Alcohol consumption in excess of 2 units/day or 14 units/week.
? Tuberculosis (TB) will be excluded by a structured symptom questionnaire.
? Receiving drugs other than the study medication known to potently induce or inhibit CYP3A4 or alter the PK of LPV
? Receiving drugs other than the study drugs whose PK is known to be altered by Aluvia?.
? Known or suspected pregnancy.
? Women of child-bearing potential who are not using a recognized form of contraception


Age minimum: 18 Year
Age maximum: 100 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
Tuberculosis
null

Primary Outcome(s)

The pharmacokinetics of adjusted dose lopinavir/ritonavir when dosed with rifampicin

Secondary Outcome(s)

Safety of adjusted dose lopinavir/ritonavir when dosed with rifampicin.

Secondary ID(s)

UCT REC 422/2007 & N2/19/8/2(2262)(2262)

Source(s) of Monetary Support

EDCDTP