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

President and Fellows of Harvard College

Status: Completed

Conditions: HIV Infection

Treatments: Drug: Ritonavir-boosted indinavir

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00197639

R01HD042964

HSC 10913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)