TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
NCT00023413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2012-06-05
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.
Conditions
- HIV Infections
- Tuberculosis
Interventions
- DRUG
-
Rifabutin
- DRUG
-
Efavirenz
Sponsors & Collaborators
-
US Department of Veterans Affairs
collaborator FED -
Centers for Disease Control and Prevention
lead FED
Principal Investigators
-
Marc Weiner, MD · San Antonio VAMC, San Antonio TX
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-11-30
- Primary Completion
- 2004-02-29
- Completion
- 2004-02-29
Countries
- United States
- Canada
Study Locations
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