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| ID | Type | Description | Link |
|---|---|---|---|
| 11560 | Registry Identifier | DAIDS ES |
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| Name | Class |
|---|---|
| Warner Lambert - Parke Davis | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | All eligible study participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuberculin Purified Protein Derivative | Drug | Administered intradermally at 5 TU per 0.1 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the percentage of HIV-infected individuals who demonstrate the booster effect | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Thompson C | Study Chair | |
| Gordin F | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill Health Corp | New Haven | Connecticut | 06519 | United States | ||
| Wilmington Hosp / Med Ctr of Delaware |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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) | ||
| 7881675 | Background | 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. |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| D017088 | AIDS-Related Opportunistic Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000386 | AIDS-Related Complex |
| D006968 | Hypersensitivity, Delayed |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D009894 | Opportunistic Infections |
| D012897 | Slow Virus Diseases |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D014373 | Tuberculin |
| ID | Term |
|---|---|
| D000942 | Antigens, Bacterial |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
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