Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000955
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
1999-11-02
Brief Title:
Two-Stage Tuberculin PPD Skin Testing in Individuals With Human Immunodeficiency Virus HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Two-Stage Tuberculin PPD Skin Testing in Individuals With Human Immunodeficiency Virus HIV Infection
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hosts 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 hosts 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 hosts 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11560 | REGISTRY | DAIDS ES | None |