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

Study Overview
=================
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.

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

Conditions
-----------------
HIV Infections, Tuberculosis

Intervention / Treatment
-----------------
* Drug: Tuberculin Purified Protein Derivative


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>All eligible study participants | Drug: Tuberculin Purified Protein Derivative<br>* Administered intradermally at 5 TU per 0.1 mL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the percentage of HIV-infected individuals who demonstrate the booster effect |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics |  | Throughout study | 
| To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories |  | Throughout study | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Immunologic Tests, Tuberculin, Tuberculin Test, AIDS-Related Opportunistic Infections, Injections, Intradermal, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed