Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
- Conditions
- HIV InfectionsTuberculosis
- Interventions
- Registration Number
- NCT00000955
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 864
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Tuberculin Purified Protein Derivative All eligible study participants
- Primary Outcome Measures
Name Time Method To estimate the percentage of HIV-infected individuals who demonstrate the booster effect Throughout study
- Secondary Outcome Measures
Name Time Method To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test After the second PPD skin test To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories Throughout study To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics Throughout study
Trial Locations
- Locations (14)
Wilmington Hosp / Med Ctr of Delaware
🇺🇸Wilmington, Delaware, United States
Clinical Directors Network of Region II
🇺🇸New York, New York, United States
Veterans Administration Med Ctr / Regional AIDS Program
🇺🇸Washington, District of Columbia, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Hill Health Corp
🇺🇸New Haven, Connecticut, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Addiction Research and Treatment Corp
🇺🇸Brooklyn, New York, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Comprehensive AIDS Alliance of Detroit
🇺🇸Detroit, Michigan, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States