Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00197639

Enrollment

Registered

2005-09-20

Start date

2006-09-30

Completion date

2010-08-31

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

indinavir, HIV, ritonavir, pharmacokinetics, Thailand

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.

Interventions

DRUGRitonavir-boosted indinavir

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Exclusion criteria

* Current active substance or alcohol abuse * Active opportunistic infection * Chronic malabsorption or diarrhea * Other clinically significant disease * Certain lab values (e.g. hemoglobin \< 8.0 mg/dL)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026