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NCT00023400 · ClinicalTrials.gov registry record · Phase 4
TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
A Phase 4 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00023400 is a Phase 4 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 20 participants.
The verdict
NCT00023400, a Phase 4 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Nelfinavir
- DRUG Rifabutin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2000-02 |
| Est. Completion | 2002-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00023400
The ClinicalTrials.gov registry entry for NCT00023400 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nelfinavir is the first listed.
NCT00023400 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00023400 about?
NCT00023400 is a clinical study titled "TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB". 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 tuberculosi...
What is the current status of trial NCT00023400?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2000-02. Estimated completion is 2002-02.
What interventions are being tested in trial NCT00023400?
The interventions under investigation include: Nelfinavir (DRUG), Rifabutin (DRUG).
Who is sponsoring clinical trial NCT00023400?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
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