A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin

NCT00000778 | Completed Phase 1

• 1 other identifier: DATRI 008
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 10

Brief Summary

To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB). Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.

Conditions

HIV Infections; Tuberculosis

Keywords

Isoniazid; Tuberculosis, Pulmonary; Pyridoxine; Ofloxacin; AIDS-Related Opportunistic Infections; Drug Evaluation; Acquired Immunodeficiency Syndrome; Sputum; Colony Count, Microbial

Interventions

Isoniazid DRUG

Pyridoxine hydrochloride DRUG

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed in all patients:
• Antacids if administered more than 2 hours before or after study drug.
• Allowed in isoniazid patients:
• Anticonvulsant therapy if blood levels are monitored.
• Allowed in levofloxacin patients:
• Acceptable medications other than antacids if administered at least 2 hours before or 1 hour after study drug.
• Anticonvulsant therapy, theophylline, or warfarin if doses are monitored.
• Patients must have:
• Presumptive active pulmonary TB.
• No clinical evidence of central nervous system or miliary tuberculosis.
• NOTE:
• Both HIV-positive and HIV-negative patients are eligible.
• NOTE:
• Pregnant women may be enrolled in the isoniazid cohort only.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Active or suspected MAI infection.
• Active or suspected hepatitis.
• Any other serious acute infection, diabetes, chronic obstructive pulmonary disease, malignancy requiring chemotherapy, or major organ dysfunction.
• Extreme illness or toxic appearance.
• Pregnancy (if entering the levofloxacin portion of the study).
• Concurrent Medication:
• Excluded:
• All standard TB therapies.
• Clofazimine.
• Rifabutin.
• Quinolones.
• Aminoglycosides.
• Corticosteroids.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (10)

Univ of Alabama at Birmingham

Birmingham, Alabama, 352336505, United States

Location

UCLA Med Ctr

Los Angeles, California, 900951793, United States

Location

Harbor - UCLA Med Ctr

Torrance, California, 90502, United States

Location

Broward Gen Med Ctr

Fort Lauderdale, Florida, 33316, United States

Location

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, 33136, United States

Location

Univ of Illinois

Chicago, Illinois, 60622, United States

Location

Tulane Univ Med School

New Orleans, Louisiana, 701122699, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Univ TX Galveston

Galveston, Texas, 77550, United States

Location

Baylor College of Medicine / Houston Veterans Adm Med Ctr

Houston, Texas, 77030, United States

Location

Related Publications (1)

• El-Sadr WM, Perlman DC, Matts JP, Nelson E, Cohn D, Telzak E, Chirgwin K, Salomon N, Olibrice M, Hafner R. Outcome of an induction regimen for the treatment of HIV-related tuberculosis (TB): evaluation of the addition of a quinolone. Int Conf AIDS. 1996 Jul 7-12;11(1):327 (abstract no TuB2358)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Tuberculosis; Tuberculosis, Pulmonary; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

Isoniazid; Pyridoxine; Levofloxacin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Vitamin B 6; Picolines; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hafner R

  STUDY CHAIR

• Cohn J

  STUDY CHAIR

• Egorin M

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: August 8, 2008

Record last verified: 1995-06

Locations

US (10)