HIV Infections Clinical Trial
Official title:
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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