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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2001

Last Updated Date

September 1, 2005

Start Date ^†

February 2000

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00023400 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Brief Summary

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 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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^†

HIV Infections
Tuberculosis

Intervention ^†

Drug: Nelfinavir
Drug: Rifabutin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

February 2002

Primary Completion Date

Eligibility Criteria ^†

- Patients with HIV-related tuberculosis

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00023400

Responsible Party

Secondary IDs ^††

23B

Study Sponsor ^†

Centers for Disease Control and Prevention

Collaborators ^††

Department of Veterans Affairs

Investigators ^†

Study Chair:

Debra Benator, MD

Washington, D.C. VAMC

Information Provided By

Centers for Disease Control and Prevention

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.