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NCT00000950 Clinical Trial

Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

HIV Infections Clinical Trial

Official title:
Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000950
Other study ID # ACTG 309
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated March 1, 2011

Study information
Verified date March 2011
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date May 2002
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ethambutol hydrochloride

• Isoniazid

• Pyrazinamide

• Pyridoxine hydrochloride

• Rifampin

Locations
Country Name City State
United States Emory Univ Atlanta Georgia
United States SUNY / Health Sciences Ctr at Brooklyn Brooklyn New York
United States MetroHealth Med Ctr Cleveland Ohio
United States Queens Med Ctr Honolulu Hawaii
United States Univ of Hawaii Honolulu Hawaii
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States University of Miami (Pediatric) Miami Florida
United States Tulane Univ School of Medicine New Orleans Louisiana
United States Beth Israel Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr New York New York
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Harbor UCLA Med Ctr Torrance California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Perlman DC, Segal Y, Rosenkranz S, Rainey PM, Peloquin CA, Remmel RP, Chirgwin K, Salomon N, Hafner R; ACTG 309 Team. The clinical pharmacokinetics of pyrazinamide in HIV-infected persons with tuberculosis. Clin Infect Dis. 2004 Feb 15;38(4):556-64. Epub 2004 Jan 28. — View Citation

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