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

November 2, 1999
September 28, 2013
Not Provided
December 1992   (final data collection date for primary outcome measure)
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00000955 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • HIV Infections
  • Tuberculosis
Drug: Tuberculin Purified Protein Derivative
Administered intradermally at 5 TU per 0.1 mL
A
All eligible study participants
Intervention: Drug: Tuberculin Purified Protein Derivative

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
864
December 1992
December 1992   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000955
CPCRA 008, 11560
Not Provided
Rona Siskind, DAIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Warner Lambert - Parke Davis
Study Chair: Thompson C
Study Chair: Gordin F
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP