HIV Infections, Tuberculosis
Conditions
Keywords
tuberculosis, TB
Brief 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.
Interventions
DRUGRifabutin
DRUGEfavirenz
Sponsors
US Department of Veterans Affairs
Centers for Disease Control and Prevention
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz | — |
Secondary
| Measure | Time frame |
|---|---|
| *Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's | — |
| *Describe PK of efavirenz in this regimen | — |
| *Assess safety of concomitant rifabutin and efavirenz in HIV-TB | — |
Countries
Canada, United States
Outcome results
None listed