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

This study has been completed.
Sponsor:
Collaborator:
Warner Lambert - Parke Davis
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000955
First received: November 2, 1999
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
HIV Infections
Tuberculosis
Drug: Tuberculin Purified Protein Derivative

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • To estimate the percentage of HIV-infected individuals who demonstrate the booster effect [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test [ Time Frame: After the second PPD skin test ] [ Designated as safety issue: No ]

Estimated Enrollment: 864
Study Completion Date: December 1992
Primary Completion Date: December 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
All eligible study participants
Drug: Tuberculin Purified Protein Derivative
Administered intradermally at 5 TU per 0.1 mL

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000955

Locations
United States, Connecticut
Hill Health Corp
New Haven, Connecticut, United States, 06519
United States, Delaware
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program
Washington, District of Columbia, United States, 20422
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Clinical Directors Network of Region II
New York, New York, United States, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Warner Lambert - Parke Davis
Investigators
Study Chair: Thompson C
Study Chair: Gordin F
  More Information

Publications:
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)

Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov Identifier: NCT00000955     History of Changes
Other Study ID Numbers: CPCRA 008, 11560
Study First Received: November 2, 1999
Last Updated: September 28, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tuberculosis
Immunologic Tests
Tuberculin
Tuberculin Test
AIDS-Related Opportunistic Infections
Injections, Intradermal
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Hypersensitivity, Delayed

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014