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Completed

NCT Number: NCT00000955

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

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.

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Key information

Conditions

HIV Infections AIDS-Related Complex AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hill Health Corp, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tuberculin Purified Protein Derivative

Drug

Administered intradermally at 5 TU per 0.1 mL

Primary outcomes

  1. To estimate the percentage of HIV-infected individuals who demonstrate the booster effect

    Time frame: Throughout study

Secondary outcomes

  1. To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics

    Time frame: Throughout study

  2. To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories

    Time frame: Throughout study

  3. To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test

    Time frame: After the second PPD skin test

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Warner Lambert - Parke Davis

Registry information

Important dates

Primary completion
1992
Study completion
1992
First posted
Aug 31, 2001
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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