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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000955
• Other study ID #: CPCRA 008
• Secondary ID: 11560
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: September 28, 2013
• Est. completion date: December 1992

Study information

• Verified date: September 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: December 1992
• Est. primary completion date: December 1992
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Tuberculosis

Intervention

Drug:
• Tuberculin Purified Protein Derivative
Administered intradermally at 5 TU per 0.1 mL

Locations

Country	Name	City	State
United States	Bronx Lebanon Hosp Ctr	Bronx	New York
United States	Addiction Research and Treatment Corp	Brooklyn	New York
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan
United States	Henry Ford Hosp	Detroit	Michigan
United States	Hill Health Corp	New Haven	Connecticut
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
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	North Jersey Community Research Initiative	Newark	New Jersey
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia
United States	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Warner Lambert - Parke Davis

Country where clinical trial is conducted

United States, 

References & Publications (2)

Thompson C, Gordin F, Muth K, Daniels K, Matts J, Maiatico G, Deyton L. Two stage tuberculin (PPD) skin testing in individuals with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):140 (abstract no PuB 7546)

Webster CT, Gordin FM, Matts JP, Korvick JA, Miller C, Muth K, Brown LS, Besch CL, Kumi JO, Salveson C, et al. Two-stage tuberculin skin testing in individuals with human immunodeficiency virus infection. Community Programs for Clinical Research on AIDS. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):805-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the percentage of HIV-infected individuals who demonstrate the booster effect		Throughout study	No
Secondary	To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics		Throughout study	No
Secondary	To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories		Throughout study	No
Secondary	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	No