Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000955

Collaborator

Warner Lambert - Parke Davis (Industry)

864

Enrollment

Locations

Arm

61.7

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: Tuberculin Purified Protein Derivative	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

864 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

Actual Primary Completion Date :

Dec 1, 1992

Actual Study Completion Date :

Dec 1, 1992

Arms and Interventions

Arm	Intervention/Treatment
Other: A All eligible study participants	Drug: Tuberculin Purified Protein Derivative Administered intradermally at 5 TU per 0.1 mL

Arm

Intervention/Treatment

Other: A

All eligible study participants

Drug: Tuberculin Purified Protein Derivative

Administered intradermally at 5 TU per 0.1 mL

Outcome Measures

Primary Outcome Measures

To estimate the percentage of HIV-infected individuals who demonstrate the booster effect [Throughout study]

Secondary Outcome Measures

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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

HIV infection.
Negative PPD skin test within previous 7-28 days.

Exclusion Criteria

Concurrent Medication:

Excluded:

Steroids.
Live viral vaccines.
Antihistamines.
Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.

Patients with the following prior conditions are excluded:

History of documented positive PPD skin test.
History of tuberculosis or who are presently receiving chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.
History of sensitivity to tuberculin or components of PPD.

Prior Medication:

Excluded:

Live viral vaccine within the past 4 weeks.
Steroid therapy within the past 4 weeks.
Antihistamines within the past week.
Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hill Health Corp	New Haven	Connecticut	United States	06519
2	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
3	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia	United States	20422
4	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
5	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
6	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan	United States	48201
7	Henry Ford Hosp	Detroit	Michigan	United States	48202
8	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
9	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10456
10	Addiction Research and Treatment Corp	Brooklyn	New York	United States	11201
11	Clinical Directors Network of Region II	New York	New York	United States	10011
12	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
13	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
14	Richmond AIDS Consortium	Richmond	Virginia	United States	23298