Clinical trial NCT00197639: Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: indinavir, HIV, ritonavir, pharmacokinetics, Thailand
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-09-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected Thai adults

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.

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.

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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Prapokklao Hospital
state: Chanthaburi
city: Mae Rim
country: Thailand
facility: Nakornping Hospital
state: Chiang Mai
city: Muang
country: Thailand
facility: Chonburi Hospital
state: Chonburi
city: Muang
country: Thailand
facility: Phayao Provincial Hospital
state: Phayao
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Marc Lallemant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/jac/dki143. Epub 2005 May 9.