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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention Department of Veterans Affairs |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00023400 |
Purpose
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.
| Condition | Intervention | Phase |
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HIV Infections Tuberculosis |
Drug: Nelfinavir Drug: Rifabutin |
Phase IV |
| MedlinePlus related topics: | AIDS Tuberculosis |
| Drug Information available for: | Nelfinavir Nelfinavir Mesylate Rifabutin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2000 |
| Estimated Study Completion Date: | February 2002 |
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations |
Show 23 Study Locations |
| Study Chair: | Debra Benator, MD | Washington, D.C. VAMC |
More Information
(Click here for more information about the Tuberculosis Trials Consortium(TBTC)
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| Study ID Numbers: | CDC-NCHSTP-2587, 23B |
| First Received: | September 6, 2001 |
| Last Updated: | September 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00023400 |
| Health Authority: | United States: Food and Drug Administration |
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