Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
2 other identifiers
interventional
864
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
December 1, 1992
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 1, 2013
September 1, 2013
November 2, 1999
September 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect
Throughout study
Secondary Outcomes (3)
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
Study Arms (1)
A
OTHERAll eligible study participants
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV infection.
- Negative PPD skin test within previous 7-28 days.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Hill Health Corp
New Haven, Connecticut, 06519, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201, United States
Clinical Directors Network of Region II
New York, New York, 10011, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Richmond AIDS Consortium
Richmond, Virginia, 23298, United States
Related 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)
BACKGROUNDWebster 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.
PMID: 7881675BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thompson C
- STUDY CHAIR
Gordin F
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
December 1, 1992
Study Completion
December 1, 1992
Last Updated
October 1, 2013
Record last verified: 2013-09