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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000955

Enrollment

864

Registered

2001-08-31

Start date

Unknown

Completion date

1992-12-31

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Tuberculosis

Keywords

Tuberculosis, Immunologic Tests, Tuberculin, Tuberculin Test, AIDS-Related Opportunistic Infections, Injections, Intradermal, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed

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.

Interventions

DRUGTuberculin Purified Protein Derivative

Administered intradermally at 5 TU per 0.1 mL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect	Throughout study

Secondary

Measure	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	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026