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

NCT ID: NCT00197639

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infection

Keywords

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indinavir, HIV, ritonavir, pharmacokinetics, Thailand

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ritonavir-boosted indinavir

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Principal Investigators

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Marc Lallemant

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

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Prapokklao Hospital

Muang, Changwat Chanthaburi, Thailand

Site Status

Chonburi Hospital

Muang, Changwat Chon Buri, Thailand

Site Status

Phayao Provincial Hospital

Muang, Changwat Phayao, Thailand

Site Status

Nakornping Hospital

Mae Rim, Chiang Mai, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 15883177 (View on PubMed)

Other Identifiers

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R01HD042964

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC 10913

Identifier Type: -

Identifier Source: org_study_id