Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infection |
Drug: Ritonavir-boosted indinavir |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
| Enrollment: | 19 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
HIV-infected Thai adults
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)
Contacts and Locations| Thailand | |
| Prapokklao Hospital | |
| Muang, Chanthaburi, Thailand, 22000 | |
| Nakornping Hospital | |
| Mae Rim, Chiang Mai, Thailand, 50180 | |
| Chonburi Hospital | |
| Muang, Chonburi, Thailand, 20000 | |
| Phayao Provincial Hospital | |
| Muang, Phayao, Thailand, 56000 | |
| Principal Investigator: | Marc Lallemant | Harvard School of Public Health |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00197639 History of Changes |
| Other Study ID Numbers: | HSC 10913, R01HD042964 |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 10, 2010 |
| Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by Harvard School of Public Health:
|
indinavir, HIV, ritonavir, pharmacokinetics, Thailand |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Indinavir |
Ritonavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013