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.

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

Interventions

DRUG

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Telzak E

• Benson C

• Chirgwin K

• Sepkowitz K

Study Design

Purpose

TREATMENT

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Completion

1998-10-31

Countries

• United States

Study Locations