TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

This study has been completed.

First Received on September 6, 2001. Last Updated on September 1, 2005 History of Changes

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	Department of Veterans Affairs
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00023413

Purpose

The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study.

Primary Objective:

To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.

Condition	Intervention	Phase
HIV Infections Tuberculosis	Drug: Rifabutin Drug: Efavirenz	Phase II

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 23C: Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid With Daily Efavirenz in Combination With Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-Infections

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Isoniazid Rifabutin Efavirenz Ftivazide

U.S. FDA Resources

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

Primary Outcome Measures:

Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz

Secondary Outcome Measures:

*Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's
*Describe PK of efavirenz in this regimen
*Assess safety of concomitant rifabutin and efavirenz in HIV-TB

Estimated Enrollment:	20
Study Start Date:	November 1999

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023413

Show 23 Study Locations

Sponsors and Collaborators

Centers for Disease Control and Prevention

Department of Veterans Affairs

Investigators

Principal Investigator:

Marc Weiner, MD

San Antonio VAMC, San Antonio TX

More Information

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00023413 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-2588, 23C
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
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections

Bacterial Infections
Isoniazid
Rifabutin
Efavirenz
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on February 12, 2012