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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Warner Lambert - Parke Davis |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000955 |
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 |
MedlinePlus related topics: | AIDS Allergy Tuberculosis |
Drug Information available for: | Tuberculin Purified Protein Derivative |
Study Type: | Interventional |
Study Design: | Screening, Open Label, Single Group Assignment |
Official Title: | Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection |
Estimated Enrollment: | 864 |
Study Start Date: | November 1999 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A
All eligible study participants
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Drug: Tuberculin Purified Protein Derivative
Administered intradermally at 5 TU per 0.1 mL
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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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
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, 071032842 | |||||
United States, New York | |||||
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |||||
New York, New York, United States, 10037 | |||||
Bronx Lebanon Hosp Ctr | |||||
Bronx, New York, United States, 10456 | |||||
Clinical Directors Network of Region II | |||||
New York, New York, United States, 10011 | |||||
Addiction Research and Treatment Corp | |||||
Brooklyn, New York, United States, 11201 | |||||
United States, Oregon | |||||
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |||||
Portland, Oregon, United States, 972109951 | |||||
United States, Virginia | |||||
Richmond AIDS Consortium | |||||
Richmond, Virginia, United States, 23298 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Warner Lambert - Parke Davis |
Study Chair: | Thompson C | |
Study Chair: | Gordin F |
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)
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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.
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Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CPCRA 008 |
First Received: | November 2, 1999 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000955 |
Health Authority: | United States: Federal Government |
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