Recruiting

Rifabutin & Efavirenz

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00018083

Conditions

Tuberculosis

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

rifabutin

isoniazid

efavirenz

Study Details

Brief summary:

The primary objective of this multi-center sub-study of USPHS Study 23: "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," is 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. Secondary objectives are: (1) To describe pharmacokinetics of both rifabutin and efavirenz in combination regimen, (2) To evaluate the safety of concomitant efavirenz and rifabutin, (3) To assess the effect on absolute neutrophil count by changing rifabutin dose and adding efavirenz to the regimen, (4) To develop models of optimal sampling times for rifabutin dosed twice a week, (5) To describe the pharmacokinetics of isoniazid in combination with efavirenz daily with two NRTIs, (6) To compare the pharmacokinetics of isoniazid with and without efavirenz.

Conditions

Tuberculosis

HIV Infections

Study ID

NCT00018083

Status verified date

Nov, 2001

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria: Eligible subjects enrolled in Study 23 or HIV-infected patients with culture confirmed or suspected tuberculosis. Subjects must be currently receiving tuberculosis therapy including twice weekly isoniazid and rifabutin and currently not receiving antiretroviral therapy. Subjects must be willing to begin an antiretrovial regimen containing efavirenz and two NRTIs (combinations defined by protocol) at the requisite dosing. Exclusion criteria include hematocrit of less than 25%, pregnant or lactating women, prior use of an NNRTI, or use of a protease inhibitor or select medications defined in the protocol. Women of child-bearing potential must agree to practice an adequate (barrier) method of birth control and submit to serum pregnancy testing with 14 days of enrollment.

Study Design

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

rifabutin

isoniazid

efavirenz

Central Contacts and Locations

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Carol D Hamilton, M.D.

919-684-3279

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Nov, 2001

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.