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

Primary Purpose

HIV Infections, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tuberculin Purified Protein Derivative
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring Tuberculosis, Immunologic Tests, Tuberculin, Tuberculin Test, AIDS-Related Opportunistic Infections, Injections, Intradermal, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hill Health Corp
  • Wilmington Hosp / Med Ctr of Delaware
  • Veterans Administration Med Ctr / Regional AIDS Program
  • AIDS Research Alliance - Chicago
  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
  • Comprehensive AIDS Alliance of Detroit
  • Henry Ford Hosp
  • North Jersey Community Research Initiative
  • Bronx Lebanon Hosp Ctr
  • Addiction Research and Treatment Corp
  • Clinical Directors Network of Region II
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Richmond AIDS Consortium

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

All eligible study participants

Outcomes

Primary Outcome Measures

To estimate the percentage of HIV-infected individuals who demonstrate the booster effect

Secondary Outcome Measures

To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics
To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories
To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test

Full Information

First Posted
November 2, 1999
Last Updated
September 28, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Warner Lambert - Parke Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00000955
Brief Title
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
Official Title
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 1992 (Actual)
Study Completion Date
December 1992 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Warner Lambert - Parke Davis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tuberculosis
Keywords
Tuberculosis, Immunologic Tests, Tuberculin, Tuberculin Test, AIDS-Related Opportunistic Infections, Injections, Intradermal, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
864 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
All eligible study participants
Intervention Type
Drug
Intervention Name(s)
Tuberculin Purified Protein Derivative
Intervention Description
Administered intradermally at 5 TU per 0.1 mL
Primary Outcome Measure Information:
Title
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics
Time Frame
Throughout study
Title
To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories
Time Frame
Throughout study
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thompson C
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gordin F
Official's Role
Study Chair
Facility Information:
Facility Name
Hill Health Corp
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Wilmington Hosp / Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Veterans Administration Med Ctr / Regional AIDS Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Comprehensive AIDS Alliance of Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Clinical Directors Network of Region II
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
7881675
Citation
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. doi: 10.1164/ajrccm.151.3.7881675.
Results Reference
background

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

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