A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

NCT00000796 | Completed

• 3 other identifiers: ACTG 238CPCRA 02611215
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 21

Brief Summary

To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.

Conditions

HIV Infections; Tuberculosis

Keywords

Isoniazid; Tuberculosis, Pulmonary; Pyrazinamide; Pyridoxine; Ofloxacin; Rifampin; AIDS-Related Opportunistic Infections; Drug Therapy, Combination; Ethambutol; Clofazimine; Acquired Immunodeficiency Syndrome; Amikacin; Drug Resistance, Microbial; Cycloserine; Capreomycin Sulfate; Ethionamide; Aminosalicylic Acids; Streptomycin; p-Aminosalicylic Acid

Interventions

Cycloserine DRUG

Ethionamide DRUG

Capreomycin sulfate DRUG

Aminosalicylic acid DRUG

Streptomycin sulfate DRUG

Ethambutol hydrochloride DRUG

Amikacin sulfate DRUG

Isoniazid DRUG

Pyrazinamide DRUG

Pyridoxine hydrochloride DRUG

Levofloxacin DRUG

Rifampin DRUG

Clofazimine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• Working diagnosis of HIV infection.
• Working diagnosis of pulmonary TB.
• Per 08/02/94 amendment, patients with confirmed MDRTB or known susceptibilities for the current episode at baseline are not eligible for the epidemiologic study only.
• FOR TREATMENT PILOT:
• Positive sputum AFB smear (or a positive sputum culture for TB within 6 months prior to study entry).
• Assessment of suspect primary, suspect acquired, AND/OR confirmed MDRTB.
• Life expectancy of at least 2 weeks.
• Age \>= 18 years for suspect MDRTB. Age \>= 13 years for confirmed MDRTB.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Known hypersensitivity or resistance to quinolones.
• Other disorders or conditions for which the study drugs are contraindicated.
• Prior Medication:
• Excluded:
• More than 6 weeks total therapy within 3 months prior to study entry using three or more drugs effective against the isolates. (Per 08/02/94 amendment, patients from protocol ACTG 222/CPCRA 019 who have MDRTB are eligible for rollover to this study regardless of treatment duration on ACTG 222/CPCRA 019.)

Sponsors & Collaborators

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

Study Sites (21)

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Interfaith Med Ctr

Brooklyn, New York, 112032098, United States

Location

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, 112032098, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Clinical Directors Network of Region II

New York, New York, 10011, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Saint Clare's Hosp and Health Ctr

New York, New York, 10019, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 100323784, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10456, United States

Location

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, 10461, United States

Location

Comprehensive Health Care Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Family Health Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Samaritan Village Inc / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Jack Weiler Hosp / Bronx Municipal Hosp

The Bronx, New York, 10465, United States

Location

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

North Central Bronx Hosp / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

Related Publications (2)

• Telzak EE, Chirgwin K, Nelson E, Matts J, Benson C, Sepkowitz K, Perlman D, El-Sadr W. Predictors for multidrug-resistant tuberculosis (MDRTB) among HIV-infected patients and response to specific MDRTB drug regimens. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:184 (abstract no 647)

  BACKGROUND

• Telzak EE, Chirgwin KD, Nelson ET, Matts JP, Sepkowitz KA, Benson CA, Perlman DC, El-Sadr WM. Predictors for multidrug-resistant tuberculosis among HIV-infected patients and response to specific drug regimens. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG), National Institutes for Health. Int J Tuberc Lung Dis. 1999 Apr;3(4):337-43.

  PMID: 10206505 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Cycloserine; Ethionamide; Capreomycin; Aminosalicylic Acid; Streptomycin; Ethambutol; Amikacin; Isoniazid; Pyrazinamide; Pyridoxine; Levofloxacin; Rifampin; Clofazimine

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)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Isonicotinic Acids; Acids, Heterocyclic; Pyridines; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Aminoglycosides; Glycosides; Carbohydrates; Ethylenediamines; Diamines; Polyamines; Amines; Kanamycin; Hydrazines; Pyrazines; Vitamin B 6; Picolines; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Phenazines; Heterocyclic Compounds, 3-Ring

Study Officials

• Telzak E

  STUDY CHAIR

• Benson C

  STUDY CHAIR

• Chirgwin K

  STUDY CHAIR

• Sepkowitz K

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1998
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (21)