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Completed

NCT Number: NCT00023413

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

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.

Completed

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Key information

Conditions

HIV Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

rifabutin

Drug

Efavirenz

Drug

Primary outcomes

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

Secondary outcomes

  1. *Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's

  2. *Describe PK of efavirenz in this regimen

  3. *Assess safety of concomitant rifabutin and efavirenz in HIV-TB

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Sep 10, 2001
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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