TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00023413
Collaborator
US Department of Veterans Affairs (U.S. Fed)
20
23
51
0.9
0
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TBTC Study 23C: Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid With Daily Efavirenz in Combination With Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections
Study Start Date
:
Nov 1, 1999
Actual Primary Completion Date
:
Feb 1, 2004
Actual Study Completion Date
:
Feb 1, 2004
Outcome Measures
Primary Outcome Measures
- Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz []
Secondary Outcome Measures
- *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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Central Arkansas Veterans Health System | Little Rock | Arkansas | United States | 72205 |
2 | LA County/USC Medical Center | Los Angeles | California | United States | 90033 |
3 | University of California, San Francisco | San Francisco | California | United States | 94110 |
4 | Denver Department of Public Health and Hospitals | Denver | Colorado | United States | 80204 |
5 | Washington, D.C. VAMC | Washington | District of Columbia | United States | 20422 |
6 | Chicago VA Medical Center (Lakeside) | Chicago | Illinois | United States | 60611 |
7 | Hines VA Medical Center | Hines | Illinois | United States | 60141 |
8 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21287-0003 |
9 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
10 | New Jersey Medical School | Newark | New Jersey | United States | 07107-3001 |
11 | New York University School of Medicine | New York | New York | United States | 10016 |
12 | Columbia University/Presbyterian Medical Center | New York | New York | United States | 10032 |
13 | Harlem Hospital Center | New York | New York | United States | 10037 |
14 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
15 | Duke University Medical Center | Durham | North Carolina | United States | 34222 |
16 | Nashville VA Medical Center | Nashville | Tennessee | United States | 37212-2637 |
17 | University of North Texas Health Science Center | Fort Worth | Texas | United States | 76107-2699 |
18 | Thomas Street Clinic | Houston | Texas | United States | 77009 |
19 | Audi L. Murphy VA Hospital | San Antonio | Texas | United States | 78284 |
20 | Seattle King County Health Department | Seattle | Washington | United States | 98104 |
21 | University of British Columbia | Vancouver | British Columbia | Canada | Canada V5Z 4R4 |
22 | University of Manitoba | Winnipeg | Manitoba | Canada | CANADA R3A 1R8 |
23 | Montreal Chest Institute McGill University | Montreal | Quebec | Canada | H2X 2P4Pq Canada |
Sponsors and Collaborators
- Centers for Disease Control and Prevention
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Marc Weiner, MD, San Antonio VAMC, San Antonio TX
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023413
Other Study ID Numbers:
- CDC-NCHSTP-2588
- 23C
First Posted:
Sep 10, 2001
Last Update Posted:
Jun 5, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Centers for Disease Control and Prevention
Additional relevant MeSH terms: