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Home > "T" Clinical Trials Conditions > Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection  Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
For Condition: HIV Infections,Tuberculosis
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Warner Lambert - Parke Davis
Synopsis: To quantitate in an HIV-infected population the percentage of patients demonstrating the "booster" phenomenon (attainment of a positive response to a second tuberculin purified protein derivative skin test when the first skin test was negative); to determine the relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to detect any relationship between the booster phenomenon and HIV exposure category. The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon.
Details: The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon. Patients who have had a negative purified protein derivative (PPD) skin test for M. tuberculosis within 7-28 days prior to study entry will receive a second PPD test by the Mantoux method (5 TU intradermally to the volar aspect of the forearm). Skin tests will be read 48-72 hours after application. Patients with a positive skin test (defined as an induration, or small hard knot, of 5 mm or greater forming beneath the skin) will be referred to their primary physicians for further evaluation.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - Negative PPD skin test within previous 7-28 days. Exclusion Criteria Concurrent Medication: Excluded: - Steroids. - Live viral vaccines. - Antihistamines. - Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis. Patients with the following prior conditions are excluded: - History of documented positive PPD skin test. - History of tuberculosis or who are presently receiving chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis. - History of sensitivity to tuberculin or components of PPD. Prior Medication: Excluded: - Live viral vaccine within the past 4 weeks. - Steroid therapy within the past 4 weeks. - Antihistamines within the past week. - Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.
Total Enrollment: 864
Location and Contact Information:
Overall Study Official:
ThompsonC, Study Chair,
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Hill Health Corp
New Haven, Connecticut, 06519
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Clinical Directors Network of Region II
New York City, New York, 10011
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: CPCRA 008;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000955
Other Hiv Infections Studies:
1. Indigenous Outreach Among Injection Drug Users to Treat and Control TB
2. Pilot Study to Evaluate Nucleic Acid Amplification Methods in the Diagnosis and Management of Active TB
3. TB Contact Investigation: Behavioral Intervention
4. Pharmacokinetics of Intermittent Isoniazid
5. Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis
Related Studies:
Other HIV Infections Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
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