HIV InfectionsNCT00000955
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
A study testing Tuberculin Purified Protein Derivative in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Tuberculin Purified Protein Derivative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 14 sitesUnited States
- Study dates
- Start not givento Dec 1992
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection.
- Negative PPD skin test within previous 7-28 days.
Who cannot join
- Concurrent Medication:
- Excluded:
- Steroids.
- Live viral vaccines.
- Antihistamines.
- Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.
Show all 16Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Hill Health Corp
New Haven, Connecticut, 06519
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Clinical Directors Network of Region II
New York, New York, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Richmond AIDS Consortium
Richmond, Virginia, 23298
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Tuberculin Purified Protein Derivative
- Keywords
- Tuberculosis, Immunologic Tests, Tuberculin, Tuberculin Test, AIDS-Related Opportunistic Infections, Injections, Intradermal, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed
- Medical subject headings
- HIV Infections, Tuberculosis, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculin Purified Protein DerivativeDrug
Administered intradermally at 5 TU per 0.1 mL
| Study group | Role | What they receive |
|---|---|---|
| A | Other | All eligible study participants Receives: Drug: Tuberculin Purified Protein Derivative |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect
Measured: Throughout study
Secondary outcomes (3)
To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics
Measured: Throughout study
To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories
Measured: Throughout study
To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test
Measured: After the second PPD skin test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Primary completionDec 1992
- Study completionDec 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Warner Lambert - Parke Davis
- Investigators
- Thompson C, Study chairGordin F, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000955
- Sponsor's protocol ID
- CPCRA 008
- Other IDs
- 11560
- Status last verified
- Sep 2013
- First submitted
- 2 Nov 1999
- Last updated
- 1 Oct 2013
- Results posted
- No
Publications
Thompson C, Gordin F, Muth K, Daniels K, Matts J, Maiatico G, Deyton L. Two stage tuberculin (PPD) skin testing in individuals with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):140 (abstract no PuB 7546)
Webster CT, Gordin FM, Matts JP, Korvick JA, Miller C, Muth K, Brown LS, Besch CL, Kumi JO, Salveson C, et al. Two-stage tuberculin skin testing in individuals with human immunodeficiency virus infection. Community Programs for Clinical Research on AIDS. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):805-8. doi: 10.1164/ajrccm.151.3.7881675.
PubMed 7881675
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
- ClinicalTrials.gov ID
- NCT00000955
- Acronym / sponsor ID
- CPCRA 008
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Tuberculosis, Immunologic Tests, Tuberculin, Tuberculin Test, AIDS-Related Opportunistic Infections, Injections, Intradermal, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Warner Lambert - Parke Davis
- Primary completion
- Dec 1992 (actual)
- Study completion
- Dec 1992 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Tuberculin Purified Protein DerivativeAll eligible study participants |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infection.
- Negative PPD skin test within previous 7-28 days.
Key exclusion criteria (16 listed)
- Steroids.
- Live viral vaccines.
- Antihistamines.
- Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.
- History of documented positive PPD skin test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuberculin Purified Protein DerivativeAdministered intradermally at 5 TU per 0.1 mL | Drug | A |
Primary outcome
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect
Time frame: Throughout study
3 secondary outcomes
To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics
Time frame: Throughout study
To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories
Time frame: Throughout study
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
- BackgroundThompson C, Gordin F, Muth K, Daniels K, Matts J, Maiatico G, Deyton L. Two stage tuberculin (PPD) skin testing in individuals with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):140 (abstract no PuB 7546)
- Background: PubMed 7881675Webster CT, Gordin FM, Matts JP, Korvick JA, Miller C, Muth K, Brown LS, Besch CL, Kumi JO, Salveson C, et al. Two-stage tuberculin skin testing in individuals with human immunodeficiency virus infection. Community Programs for Clinical Research on AIDS. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):805-8. doi: 10.1164/ajrccm.151.3.7881675.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thompson C study chair
Gordin F study chair
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuberculin Purified Protein Derivative in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.