drugset / Trial / NCT00122590
Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)
Terminated
115 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.
Timeline
- Start
- 2002-07
- Primary completion
- —
- Completion
- 2005-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INDINAVIR ANHYDROUS | Other / unclassified | — | — |
| Subject | Lopinavir | Other / unclassified | — | — |
| Subject | Nelfinavir | Other / unclassified | 625 mg | — |
| Background | Ritonavir | Other / unclassified | — | — |