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Home > "P" Clinical Trials Conditions > Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection  Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
For Condition: HIV Infections,Tuberculosis
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
Details: Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance. After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral treatment. - Pneumocystis carinii pneumonia prophylaxis. - Treatment for acute opportunistic infection/malignancy. - Aminoglycosides, quinolones or fluoroquinolones such as ciprofloxacin or ofloxacin for < 14 days for treatment of intercurrent infection. Patients must have: - HIV infection. - Signed informed consent. - Reasonably good health at time of study entry. - Perceived life expectancy of at least six months. - Allowed: - Participation in other clinical trials as long as there is no potential activity of other study drugs against Mycobacterium tuberculosis (MTb), additive toxicities between study agents, or known possible drug interactions between study drugs. Prior Medication: Allowed: - Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents with known or potential activity against M. tuberculosis. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Current active tuberculosis (confirmed or suspected). - Sensitivity or intolerance to study medication. - Acute hepatitis. - Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse. - Inability to have concomitant medications changed to avoid serious interaction with study drug. Concurrent Medication: Excluded: Quinolones, fluoroquinolones, or aminoglycosides with antituberculous activity (may be used for up to 14 days for treatment of intercurrent infection).Other agents with known or potential antituberculous activity should be avoided, including the following: - Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, and thiacetazone. Prior Medication: Excluded: - History of treatment for > 2 months with agents that have known or potential antituberculous activity other than those specifically allowed. Agents with potential or known antituberculous activity include the following: - Aminoglycosides such as amikacin, aminosalicylic acid salts, capreomycin, ciprofloxacin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, ofloxacin, pyrazinamide, quinolones or fluoroquinolones, rifabutin, rifampin, streptomycin, and thiacetazone. Patients may not have: - Current active tuberculosis. - Acute hepatitis. - Peripheral neuropathy of grade 3 or grade 4. Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues.
Total Enrollment: 2000
Location and Contact Information:
Overall Study Official:
GordinF, Study Chair,
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Johns Hopkins Univ / Brazil
Baltimore, Maryland, 21205
United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 212052179
United States
Lattimore Comprehensive Pulmonary Disease Clinic
Newark, New Jersey, 07103
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Hill Health Corp
New Haven, Connecticut, 06519
United States
Clinical Directors Network of Region II
New York City, New York, 10011
United States
Beth Israel Med Ctr
New York City, New York, 10035
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
United States
Boston Dept of Health and Hosps
Boston, Massachusetts, 02118
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Chicago Dept of Health / Speciality STD Clinic
Chicago, Illinois, 60605
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Additional Information:
Study ID Numbers: CPCRA 004; TB/PPD+,ACTG 177
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000636
Other Tuberculosis Studies:
1. A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
2. A Study to Test the Safety of Three Experimental HIV Vaccines
3. The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex
4. Zidovudine Levels in HIV Infected Patients Being Treated for HCV
5. Study of Itraconazole in Patients with Advanced HIV Infection
Related Studies:
Other Tuberculosis Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
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