Completed

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

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What is being tested

Tuberculin Purified Protein Derivative

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTwo-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
NCT00000955
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

864 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeActinomycetales InfectionsAIDS-Related ComplexBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesHypersensitivityHypersensitivity, DelayedImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesTuberculosisVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsGram-Positive Bacterial InfectionsAIDS-Related Opportunistic Infections

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

All eligible study participants

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Suspended

Hill Health Corp

New Haven, United StatesOpen Hill Health Corp in Google Maps
Suspended

Wilmington Hosp / Med Ctr of Delaware

Wilmington, United States
Suspended

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., United States
Suspended

AIDS Research Alliance - Chicago

Chicago, United States
Completed14 Study Centers