Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 2, 1999 | ||||||||
| Last Updated Date | December 17, 2012 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | December 1992 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00000955 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection | ||||||||
| Official Title ICMJE | Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection | ||||||||
| 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. |
||||||||
| Detailed Description | 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Drug: Tuberculin Purified Protein Derivative
Administered intradermally at 5 TU per 0.1 mL |
||||||||
| Study Arm (s) | A
All eligible study participants
Intervention: Drug: Tuberculin Purified Protein Derivative |
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 864 | ||||||||
| Completion Date | December 1992 | ||||||||
| Primary Completion Date | December 1992 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
|
||||||||
| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00000955 | ||||||||
| Other Study ID Numbers ICMJE | CPCRA 008 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Rona Siskind, DAIDS | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | Warner Lambert - Parke Davis | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | December 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||