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

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Tuberculosis

• Registration Number: PACTR201206000159453
• Lead Sponsor: CT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

¿HIV-infected adults (>18 yr)
¿Established on an antiretroviral regimen comprising LPV 400 mg/RTV 100 mg and 2 NRTIs > 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 (>0.20s) and QT prolongation as identified by using a QT correction formula. QT interval with Fridericia¿s correction > 480 ms.
¿Hypo or hyperkalaemia, a family history of Long QT syndrome or on medication that may prolong the QT/QTc interval.
¿Fasting cholesterol >7.77 mmol/L, fasting triglyceride > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified