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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197639
• Other study ID #: HSC 10913
• Secondary ID: R01HD042964
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 10, 2010
• Start date: September 2006
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Ritonavir-boosted indinavir

Locations

Country	Name	City	State
Thailand	Nakornping Hospital	Mae Rim	Chiang Mai
Thailand	Chonburi Hospital	Muang	Chonburi
Thailand	Phayao Provincial Hospital	Muang	Phayao
Thailand	Prapokklao Hospital	Muang	Chanthaburi

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Cressey TR, Leenasirimakul P, Jourdain G, Tod M, Sukrakanchana PO, Kunkeaw S, Puttimit C, Lallemant M. Low-doses of indinavir boosted with ritonavir in HIV-infected Thai patients: pharmacokinetics, efficacy and tolerability. J Antimicrob Chemother. 2005 Jun;55(6):1041-4. Epub 2005 May 9. — View Citation