drugset / Trial / NCT00411957
Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
Phase 1/2
Completed
22 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
Bristol-Myers Squibb · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may be higher than the acceptable range and could be associated with ATV related toxicity.
Timeline
- Start
- 2007-01
- Primary completion
- 2008-01
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atazanavir | Other / unclassified | 200 mg | — |
| Comparator | Atazanavir | Other / unclassified | 300 mg | — |