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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 |
Purpose
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 |
| 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
|
Drug: Tuberculin Purified Protein Derivative
Administered intradermally at 5 TU per 0.1 mL
|
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.
Eligibility| 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:
Contacts and Locations| 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 | |
| Study Chair: | Thompson C | |
| Study Chair: | Gordin F |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | CPCRA 008 |
| Study First Received: | November 2, 1999 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000955 History of Changes |
| Health Authority: | United States: Federal Government |
|
Tuberculosis Immunologic Tests Tuberculin Tuberculin Test AIDS-Related Opportunistic Infections |
Injections, Intradermal Acquired Immunodeficiency Syndrome AIDS-Related Complex Hypersensitivity, Delayed |
|
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases Gram-Positive Bacterial Infections |
Hypersensitivity Hypersensitivity, Delayed HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections |
|
Bacterial Infections Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Actinomycetales Infections |
Immunologic Deficiency Syndromes Virus Diseases Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Tuberculosis Retroviridae Infections |