TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
Public ClinicalTrials.gov record NCT00023400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy. Secondary Objectives: To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis. To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis. To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
Study identification
- NCT ID
- NCT00023400
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2000 (Type not available)
- Primary completion
- Not listed
- Completion
- Feb 2002 (Type not available)
- Last update posted
- Sep 5, 2005
2000 – 2002
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Arkansas Veterans Health System | Little Rock | Arkansas | 72205 | — |
| LA County/USC Medical Center | Los Angeles | California | 90033 | — |
| University of California, San Francisco | San Francisco | California | 94110 | — |
| Denver Department of Public Health and Hospitals | Denver | Colorado | 80204 | — |
| Washington, D.C. VAMC | Washington D.C. | District of Columbia | 20422 | — |
| Chicago VA Medical Center (Lakeside) | Chicago | Illinois | 60611 | — |
| Hines VA Medical Center | Hines | Illinois | 60141 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287-0003 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| New Jersey Medical School | Newark | New Jersey | 07107-3001 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| Columbia University/Presbyterian Medical Center | New York | New York | 10032 | — |
| Harlem Hospital Center | New York | New York | 10037 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 34222 | — |
| Nashville VA Medical Center | Nashville | Tennessee | 37212-2637 | — |
| University of North Texas Health Science Center | Fort Worth | Texas | 76107-2699 | — |
| Thomas Street Clinic | Houston | Texas | 77009 | — |
| Audi L. Murphy VA Hospital | San Antonio | Texas | 78284 | — |
| Seattle King County Health Department | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00023400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 5, 2005 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00023400 live on ClinicalTrials.gov.