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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.

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Tuberculosis

Intervention: 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)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Telzak E, Study Chair
Benson C, Study Chair
Chirgwin K, Study Chair
Sepkowitz K, Study Chair

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.

Clinical Details

Official title: 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.

Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

Detailed description: 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. Patients are asked a series of questions to determine epidemiologic factors that may be predictive of MDRTB. Patients who are determined to be at low risk for MDRTB will be referred to another TB treatment protocol (ACTG 222), if appropriate. Patients suspected of having primary or acquired MDRTB or those with confirmed MDRTB will be offered a regimen of anti-TB therapy from a hierarchically ordered list of drugs, based on the patient's resistance status (suspect primary MDRTB, suspect acquired MDRTB, or confirmed MDRTB). The hierarchical list is as follows: isoniazid, rifampin, ethambutol, streptomycin, levofloxacin, ethionamide, cycloserine, capreomycin, aminosalicylic acid, and clofazimine. Treatment will be administered daily for at least 6 months, then on an intermittent schedule at the clinician's discretion. Patients with confirmed MDRTB (defined as known resistance to at least isoniazid and rifampin within 6 months prior to study entry) will receive a minimum of 18 months of treatment following sputum culture conversion. Follow-up is performed every 4 weeks for 8 weeks, and then every 8 weeks.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 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.

Exclusion Criteria 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.)

Locations and Contacts

Cook County Hosp, Chicago, Illinois 60612, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States

Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States

Comprehensive Health Care Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States

Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States

Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States

Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York 10467, United States

North Central Bronx Hosp / Bronx Municipal Hosp, Bronx, New York 10467, United States

Samaritan Village Inc / Bronx Municipal Hosp, Bronx, New York 10461, United States

Interfaith Med Ctr, Brooklyn, New York 112032098, United States

SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 112032098, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Clinical Directors Network of Region II, New York, New York 10011, United States

Columbia Presbyterian Med Ctr, New York, New York 100323784, United States

Cornell Univ Med Ctr, New York, New York 10021, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Saint Clare's Hosp and Health Ctr, New York, New York 10019, United States

Additional Information

Click here for more information about Rifampin

Click here for more information about Isoniazid

Related publications:

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.


Last updated: March 30, 2012

Page last updated: August 23, 2015

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