Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Tuberculosis
Intervention: Tuberculin Purified Protein Derivative (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Thompson C, Study Chair Gordin F, Study Chair
Summary
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.
Clinical Details
Official title: Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Primary outcome: To estimate the percentage of HIV-infected individuals who demonstrate the booster effect
Secondary outcome: To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristicsTo determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test
Detailed description:
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
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hill Health Corp, New Haven, Connecticut 06519, United States
Wilmington Hosp / Med Ctr of Delaware, Wilmington, Delaware 19899, United States
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States
AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
North Jersey Community Research Initiative, Newark, New Jersey 07103, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States
Addiction Research and Treatment Corp, Brooklyn, New York 11201, United States
Clinical Directors Network of Region II, New York, New York 10011, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States
Richmond AIDS Consortium, Richmond, Virginia 23298, United States
Additional Information
Related publications: Thompson C, Gordin F, Muth K, Daniels K, Matts J, Maiatico G, Deyton L. Two stage tuberculin (PPD) skin testing in individuals with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):140 (abstract no PuB 7546) Webster CT, Gordin FM, Matts JP, Korvick JA, Miller C, Muth K, Brown LS, Besch CL, Kumi JO, Salveson C, et al. Two-stage tuberculin skin testing in individuals with human immunodeficiency virus infection. Community Programs for Clinical Research on AIDS. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):805-8.
Last updated: September 28, 2013
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