Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary from patient to patient. The study population are HIV+ Thai individuals.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pharmacokinetic Study to Assess the Inter-patient Variability of Indinavir Drug Levels When Boosted With Ritonavir in Thai Patients on Highly Active Antiretroviral Therapy|
|Study Start Date:||September 2006|
|Study Completion Date:||August 2010|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
This study will assess the inter-individual variability of indinavir drug levels, boosted with ritonavir, in Thai patients. Data will be collected in patients participating in the randomized study, "Monitoring Highly Active Antiretroviral Therapy (HAART) in HIV-infected patients in Thailand (PHPT-3)" (HSC 10668). The first 20 patents in PHPT-3 will have steady-state pharmacokinetic sparse sampling performed at pre-dose, and 1, 2.5, 4 and 12 hours after drug intake 1 and 2 months after initiating IDV/r 400/100 mg, twice daily. IDV/r plasma concentrations will be determined by high performance liquid chromatography. This spare PK data will be pooled with indinavir concentration data collected within an intensive pharmacokinetic studies of IDV/r [Cressey TR, et al 2005, JAC, 55, p1041-44]. Population means and variances of indinavir and ritonavir pharmacokinetic parameters were estimated using non-linear mixed effects regression models (NONMEM Version VI). The validity of the final model was evaluated using a visual predictive check (VPC) and bootstrap re-sampling techniques.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197639
|Muang, Chanthaburi, Thailand, 22000|
|Mae Rim, Chiang Mai, Thailand, 50180|
|Muang, Chonburi, Thailand, 20000|
|Phayao Provincial Hospital|
|Muang, Phayao, Thailand, 56000|
|Principal Investigator:||Marc Lallemant||Harvard School of Public Health|