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Home > "T" Clinical Trials Conditions > The Treatment of Tuberculosis in HIV-Infected Patients  The Treatment of Tuberculosis in HIV-Infected Patients
The Treatment of Tuberculosis in HIV-Infected Patients
For Condition: HIV Infections,Tuberculosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 650
Location and Contact Information:
Overall Study Official:
PerlmanD, Study Chair,
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Interfaith Med Ctr
Brooklyn, New York, 112032098
United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, 10461
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Meharry Med College
Nashville, Tennessee, 37203
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Clinical Directors Network of Region II
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: ACTG 222; CPCRA 019
Study Start Date:
Record last reviewed: May 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001033
Other Hiv Infections Studies:
1. Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
2. New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
3. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
4. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
5. The Safety and Effectiveness of 935U83 in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
The Treatment of Tuberculosis in HIV-Infected Patients
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