TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen |
- 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.
- 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.
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00023400
Show 23 Study Locations
| Study Chair: | Debra Benator, MD | Washington, D.C. VAMC |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00023400 History of Changes |
| Other Study ID Numbers: | CDC-NCHSTP-2587, 23B |
| Study First Received: | September 6, 2001 |
| Last Updated: | September 1, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centers for Disease Control and Prevention:
|
tuberculosis TB |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Tuberculosis Actinomycetales Infections Bacterial Infections Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases |
Virus Diseases Nelfinavir Rifabutin Anti-Bacterial Agents Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antibiotics, Antitubercular Antitubercular Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors |
ClinicalTrials.gov processed this record on February 25, 2015