TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

This study has been completed.

Sponsor:

Collaborator:

VA Office of Research and Development

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00023400

First received: September 6, 2001

Last updated: September 1, 2005

Last verified: September 2005

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Rifabutin Nelfinavir Nelfinavir Mesylate

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

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.

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.


Estimated Enrollment:	20
Study Start Date:	February 2000
Estimated Study Completion Date:	February 2002

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with HIV-related tuberculosis

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00023400

Show 23 Study Locations

Sponsors and Collaborators

Centers for Disease Control and Prevention

VA Office of Research and Development

Investigators


Study Chair:	Debra Benator, MD	Washington, D.C. VAMC

More Information

Additional Information:

(Click here for more information about the Tuberculosis Trials Consortium(TBTC) This link exits the ClinicalTrials.gov site


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:


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	Rifabutin Nelfinavir Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents

ClinicalTrials.gov processed this record on September 30, 2016

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