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Tracking Information | |||||
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First Received Date † | September 6, 2001 | ||||
Last Updated Date | September 1, 2005 | ||||
Start Date † | February 2000 | ||||
Current Primary Outcome Measures † |
Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00023400 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB | ||||
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 | 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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 20 | ||||
Completion Date | February 2002 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | - Patients with HIV-related tuberculosis |
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00023400 | ||||
Responsible Party | |||||
Secondary IDs †† | 23B | ||||
Study Sponsor † | Centers for Disease Control and Prevention | ||||
Collaborators †† | Department of Veterans Affairs | ||||
Investigators † |
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Information Provided By | Centers for Disease Control and Prevention | ||||
Verification Date | September 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |