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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD042964 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir-boosted indinavir | Drug |
Inclusion Criteria:
Exclusion Criteria:
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HIV-infected Thai adults
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| Name | Affiliation | Role |
|---|---|---|
| Marc Lallemant | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prapokklao Hospital | Muang | Changwat Chanthaburi | 22000 | Thailand | ||
| Chonburi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15883177 | Background | 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. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Muang |
| Changwat Chon Buri |
| 20000 |
| Thailand |
| Phayao Provincial Hospital | Muang | Changwat Phayao | 56000 | Thailand |
| Nakornping Hospital | Mae Rim | Chiang Mai | 50180 | Thailand |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |