Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000950

Collaborator

(none)

Enrollment

Locations

3.8

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: Ethambutol hydrochloride Drug: Isoniazid Drug: Pyrazinamide Drug: Pyridoxine hydrochloride Drug: Rifampin	N/A

Detailed Description

Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly).

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis

Actual Primary Completion Date :

May 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive and have tuberculosis.
Are 13 years of age or older.
Have written, informed consent of parent or guardian if you are under 18 years of age.
Agree to practice abstinence or use barrier methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

Have any other disorder or condition which might cause study treatment to be undesirable.
Are pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
2	Harbor UCLA Med Ctr	Torrance	California	United States	90502
3	University of Miami (Pediatric)	Miami	Florida	United States	33136
4	Emory Univ	Atlanta	Georgia	United States	30308
5	Queens Med Ctr	Honolulu	Hawaii	United States	96816
6	Univ of Hawaii	Honolulu	Hawaii	United States	96816
7	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
8	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York	United States	112032098
9	Beth Israel Med Ctr	New York	New York	United States	10003
10	St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr	New York	New York	United States	10021
11	Mount Sinai Med Ctr	New York	New York	United States	10029
12	MetroHealth Med Ctr	Cleveland	Ohio	United States	441091998
13	Univ of Pennsylvania at Philadelphia	Philadelphia	Pennsylvania	United States	19104