HIV/AIDS Tuberculosis
Conditions
Interventions
Rifampicin
Sponsors
UCT
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetics of adjusted dose lopinavir/ritonavir when dosed with rifampicin | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of adjusted dose lopinavir/ritonavir when dosed with rifampicin. | — |
Countries
South Africa
Contacts
Public ContactEric Decloedt
Outcome results
None listed