Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

Completed · Not applicable

Conditions studied: HIV Infections, Tuberculosis

In brief

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.

Key facts

Study ID

NCT00000955

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

864

Expected to finish

1992-12-01

Last updated by the study team

2013-10-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV infection.
• Negative PPD skin test within previous 7-28 days.

You may not qualify if…

• 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.

Where it is running

• Hill Health Corp — New Haven, Connecticut, United States
• Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
• Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Addiction Research and Treatment Corp — Brooklyn, New York, United States
• Clinical Directors Network of Region II — New York, New York, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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