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TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB

Centers for Disease Control and Prevention (CDC) logo

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Tuberculosis
HIV Infections

Treatments

Drug: Rifabutin
Drug: Isoniazid

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00023348
CDC-NCHSTP-2173
23A

Details and patient eligibility

About

Primary Objectives:

  1. To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.

Secondary Objectives:

  1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
  2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
  3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
  4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

Full description

This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  1. Patient enrolled in TBTC Study 23
  2. Informed consent

Exclusion:

  1. Severe anemia (Hct <25%)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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