Trial intelligence / Profile preview

PK of Isoniazid and Rifabutin in HIV-Related TB (TBTC Study 23A)

NCT00023348Phase 3

Key facts

Status: Completed
Start: Jul 1999
Countries: 2
Sponsor: Centers for Disease Control and Prevention
Modality: Small Molecules

Drugs: rifabutin
Conditions: Tuberculosis (TB)

Overview

Phase 3, open-label, single-arm trial of rifabutin in Tuberculosis (TB), sponsored by Centers for Disease Control and Prevention. Primary endpoint: Proportion of patients with abnormal pharmacokinetic parameters for isoniazid and rifabutin. Started Jul 1999; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

TBTC Study 23 Participants
Patients with HIV-related TB receiving Rifabutin-based regimen

Who it enrols

Patients enrolled in TBTC Study 23 with HIV-related tuberculosis. Excludes patients with severe anemia (Hct < 25%).

Endpoints

Primary

Proportion of patients with abnormal pharmacokinetic parameters for isoniazid and rifabutinSteady state (at least 2 weeks after start)

Secondary

Risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin
Correlation between pharmacokinetic parameters and toxicity
Correlation between pharmacokinetic parameters and efficacy
Correlation of phenotypic INH acetylator status with genotypic data

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