drugset / Trial / NCT00023413
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
Phase 2
Completed
20 enrolled
Centers for Disease Control and Prevention
US Department of Veterans Affairs · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study. Primary Objective: To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.
Timeline
- Start
- 1999-11
- Primary completion
- 2004-02
- Completion
- 2004-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efavirenz | Other / unclassified | 600 mg | — |
| Subject | Rifabutin | Small molecule | 300 mg | — |
| Subject | Rifabutin | Small molecule | 600 mg | — |