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The Treatment of Tuberculosis in HIV-Infected Patients

Primary Purpose

HIV Infections, Tuberculosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Isoniazid
Pyrazinamide
Pyridoxine hydrochloride
Levofloxacin
Rifampin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Isoniazid, Tuberculosis, Pulmonary, Pyrazinamide, Pyridoxine, Ofloxacin, Rifampin, AIDS-Related Opportunistic Infections, Ethambutol, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC CRS
  • Howard University Hosp., Div. of Infectious Diseases, ACTU
  • Univ. of Miami AIDS CRS
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Cook County Hosp. CORE Ctr.
  • Johns Hopkins Adult AIDS CRS
  • SUNY - Buffalo, Erie County Medical Ctr
  • NY Univ. HIV/AIDS CRS
  • Cornell University A2201
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • Univ. of Cincinnati CRS
  • Hosp. of the Univ. of Pennsylvania CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001033
Brief Title
The Treatment of Tuberculosis in HIV-Infected Patients
Official Title
The Treatment of Pulmonary Mycobacterium Tuberculosis in HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens. ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tuberculosis
Keywords
Isoniazid, Tuberculosis, Pulmonary, Pyrazinamide, Pyridoxine, Ofloxacin, Rifampin, AIDS-Related Opportunistic Infections, Ethambutol, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
650 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethambutol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Isoniazid
Intervention Type
Drug
Intervention Name(s)
Pyrazinamide
Intervention Type
Drug
Intervention Name(s)
Pyridoxine hydrochloride
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Type
Drug
Intervention Name(s)
Rifampin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perlman D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
El-Sadr W
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Howard University Hosp., Div. of Infectious Diseases, ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell University A2201
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
9597244
Citation
el-Sadr WM, Perlman DC, Matts JP, Nelson ET, Cohn DL, Salomon N, Olibrice M, Medard F, Chirgwin KD, Mildvan D, Jones BE, Telzak EE, Klein O, Heifets L, Hafner R. Evaluation of an intensive intermittent-induction regimen and duration of short-course treatment for human immunodeficiency virus-related pulmonary tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG). Clin Infect Dis. 1998 May;26(5):1148-58. doi: 10.1086/520275.
Results Reference
background
PubMed Identifier
9332519
Citation
Perlman DC, el-Sadr WM, Nelson ET, Matts JP, Telzak EE, Salomon N, Chirgwin K, Hafner R. Variation of chest radiographic patterns in pulmonary tuberculosis by degree of human immunodeficiency virus-related immunosuppression. The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). The AIDS Clinical Trials Group (ACTG). Clin Infect Dis. 1997 Aug;25(2):242-6. doi: 10.1086/514546.
Results Reference
background
PubMed Identifier
9342069
Citation
Perlman DC, El Sadr WM, Heifets LB, Nelson ET, Matts JP, Chirgwin K, Salomon N, Telzak EE, Klein O, Kreiswirth BN, Musser JM, Hafner R. Susceptibility to levofloxacin of Myocobacterium tuberculosis isolates from patients with HIV-related tuberculosis and characterization of a strain with levofloxacin monoresistance. Community Programs for Clinical Research on AIDS 019 and the AIDS Clinical Trials Group 222 Protocol Team. AIDS. 1997 Oct;11(12):1473-8. doi: 10.1097/00002030-199712000-00011.
Results Reference
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The Treatment of Tuberculosis in HIV-Infected Patients

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