Completed

Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

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What is being tested

Ethambutol hydrochloride

+ Isoniazid
+ Pyrazinamide
Drug
Who is being recruted

HIV Infections

+ Tuberculosis
Over 13 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 2, 2011
Sourced from a government-validated database.Claim as a partner

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. 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).

Official TitlePharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 2, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Tuberculosis
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
Univ of Southern California / LA County USC Med CtrLos Angeles, United StatesSee the location
Suspended
Harbor UCLA Med CtrTorrance, United States
Suspended
University of Miami (Pediatric)Miami, United States
Suspended
Emory UnivAtlanta, United States
Completed13 Study Centers