Status:
UNKNOWN
Adjusting Antiretroviral Therapy Dosage Using Therapeutic Drug Monitoring
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Swiss HIV Cohort Study
Conditions:
Human Immunodeficiency Virus
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background Low concentrations of protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs) are associated with an increased risk of virological failure. Likewise, excessive...
Eligibility Criteria
Inclusion
- Stable regimen including either EFV or LPV/r
- HIVRNA below 40 copies since at least 3 months
- Antiretroviral drug concentration (EFV, LPV/r) plasma concentration at screening above P75
- Signed consent for the SHCS genetics core project
Exclusion
- Concomitant medication:Amiodarone, bepidril, flecainide, propafenone, quinidine,Astemizole, terfenadine,Dihydroergotamine, ergotamine,Midazolam, triazolam,Cisapride,Pimozide,Rifabutin
- Renal or hepatic impairment
- Pregnancy or wish to become pregnant within the next 6 months
- Both EFV and LPV/r as part of the antiretroviral drug regimen
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00836212
Start Date
March 1 2008
End Date
April 1 2009
Last Update
July 23 2009
Active Locations (1)
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1
University Hopistal of Geneva
Geneva, Canton of Geneva, Switzerland, 1211