TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
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ClinicalTrials.gov Identifier: NCT00023400 |
Recruitment Status
:
Completed
First Posted
: September 10, 2001
Last Update Posted
: September 5, 2005
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Drug: Nelfinavir Drug: Rifabutin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2000 |
Study Completion Date : | February 2002 |
- 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.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- Patients with HIV-related tuberculosis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023400

Study Chair: | Debra Benator, MD | Washington, D.C. VAMC |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00023400 History of Changes |
Other Study ID Numbers: |
CDC-NCHSTP-2587 23B |
First Posted: | September 10, 2001 Key Record Dates |
Last Update Posted: | September 5, 2005 |
Last Verified: | September 2005 |
Keywords provided by Centers for Disease Control and Prevention:
tuberculosis TB |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Nelfinavir Rifabutin HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-Bacterial Agents Antibiotics, Antitubercular Antitubercular Agents |