drugset / Trial / NCT00697892
Pharmacokinetic Interactions Between Antiretroviral Agents and Antimalarial Drug Combinations
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to determine in healthy volunteers whether certain anti-HIV medications (lopinavir/ritonavir and efavirenz) affect the drug levels of certain anti-malarial medications (artesunate/ amodiaquine and artemether/ lumefantrine) and vice versa. Since these drugs are degraded using overlapping pathways in the liver, it is predicted that changes in both drug level and overall drug exposure will be observed.
Timeline
- Start
- 2005-07
- Primary completion
- 2008-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artemether | Small molecule | 20 mg | — |
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Lopinavir | Other / unclassified | 200 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 50 mg | Oral |
| Subject | lumefantrine | Small molecule | 120 mg | — |