Overview

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

Status:
Completed
Trial end date:
1992-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Warner Lambert - Parke Davis
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.