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

Harvard School of Public Health (HSPH)4 sites in 1 country19 target enrollmentSeptember 2006

ConditionsHIV Infection

DrugsRitonavir-boosted indinavir

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infection
Sponsor: Harvard School of Public Health (HSPH)
Enrollment: 19
Locations: 4
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

August 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

•Subjects enrolled in the parent study, "Monitoring HAART Therapy in HIV-Infected Patients in Thailand (PHPT-3)" and agreeing to additional blood sampling and tests.