The Treatment of Pulmonary Mycobacterium Tuberculosis in HIV Infection
Ethambutol hydrochloride
+ Isoniazid
+ Pyrazinamide
Blood-Borne Infections+25
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established. ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined. PER 5/30/95 AMENDMENT: Patients who have received an acceptable induction regimen prior to study entry and have been found to be susceptible to isoniazid and rifampin with no pyrazinamide resistance are randomized to receive either isoniazid or rifampin plus vitamin B6 biweekly for 18 or 31 weeks. Patients are evaluated at months 1, 2, 4, 6, 8, and 10, and every 4 months thereafter. Minimum follow-up is 1.5 years. ORIGINAL: In the induction phase, patients enrolled in "drug-susceptible" areas (defined as metropolitan areas with a resistance rate for isoniazid therapy of less than 10 percent) receive four drugs: isoniazid (plus pyridoxine), rifampin, pyrazinamide, and ethambutol. Patients enrolled in "drug-resistant" areas (resistance rate for isoniazid of 10 percent or higher) receive the four-drug regimen with or without a fifth drug, levofloxacin. After 8 weeks of induction, patients with multi-drug resistance are removed from study regimens; all other patients enter a continuation phase. Pansusceptible patients (showing susceptibility to all first-line anti-TB drugs) receive two study drugs for an additional 18 or 31 weeks; patients with isoniazid-resistant (or intolerant) TB receive two or three study drugs for an additional 44 weeks, while those with rifampin-resistant TB receive two or three study drugs for an additional 70 weeks. Patients are evaluated every 2 weeks in the induction phase and every 12 weeks in the continuation phase. Minimum follow-up is 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.650 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Patients must have: INDUCTION PHASE (ELIMINATED PER 5/30/95 AMENDMENT). HIV infection. Diagnosis of pulmonary TB. NOTE: Patients from "susceptible" areas may be 13 years of age or older. Patients from "resistant" areas must be 18 years of age or older. CONTINUATION PHASE. Successful completion of induction phase and confirmation of TB by culture and susceptibility results. Susceptibility to and tolerance of isoniazid and rifampin and no resistance to pyrazinamide. HIV infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Multi-drug resistance to at least isoniazid and rifampin or known to have had close contact with a person with known multi-drug resistant TB. Known treatment-limiting reaction to any of the study drugs. Other disorders or conditions for which the study drugs are contraindicated. Concurrent Medication: Excluded: Other medications with anti-TB activity.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., United StatesUniv. of Miami AIDS CRS
Miami, United StatesUniv. of Hawaii at Manoa, Leahi Hosp.
Honolulu, United States