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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 |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Nelfinavir Drug: Rifabutin |
Phase IV |
| 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 |
- Patients with HIV-related tuberculosis
Contacts and Locations
Show 23 Study Locations| Study Chair: | Debra Benator, MD | Washington, D.C. VAMC |
More Information
| Study ID Numbers: | CDC-NCHSTP-2587, 23B |
| Study First Received: | September 6, 2001 |
| Last Updated: | September 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00023400 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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tuberculosis TB |
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Bacterial Infections HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Rifabutin Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases |
Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Antitubercular Agents Nelfinavir Retroviridae Infections |
|
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Rifabutin Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents Therapeutic Uses Tuberculosis Nelfinavir Retroviridae Infections HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
