The Effects of Prednisone on HIV Levels and the Immune System
NCT ID: NCT00000921
Last Updated: 2011-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
1996-08-31
Brief Summary
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Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell responses. Prednisone may be able to lower the level of HIV in the body (viral load) by reducing the number of cells that HIV can infect. At the same time, prednisone may be able to increase CD4 cell counts (cells of the immune system that fight infection).
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Detailed Description
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Patients are separated into 2 arms according to whether or not they are currently receiving a protease inhibitor (PI) as part of their antiretroviral (ARV) therapy regimen (PI vs no PI therapy). Arm I: Current stable ARV therapy plus prednisone for 8 weeks, followed by 4 weeks at half the prior dose, then a 2-week taper. Arm II: Current stable ARV therapy plus prednisone placebo for 12 weeks.
Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Prednisone
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a CD4 cell count of 200-600 cells/mm3 within 30 days of study entry. (This study has been changed. You now must have a CD4 cell count of 200-700 cells/mm3 within 45 days of study entry.)
* Have had your viral load measured within 30 days of study entry.
* Have been on stable anti-HIV therapy with at least two anti-HIV agents for at least 12 weeks, and you intend to remain on this therapy during the study.
* Are at least 18 years of age.
* Agree to abstain from sex or use effective methods of birth control during the study and for 30 days after.
Exclusion Criteria
* Abuse alcohol or drugs or have a serious psychological condition.
* Are allergic to prednisone or other corticosteroids.
* Have a history of opportunistic (AIDS-related) infections, including cytomegalovirus (CMV), Mycobacterium avium complex (MAC), or Kaposi's sarcoma (KS).
* Have a history of a serious medical condition, including heart problems, tuberculosis (TB), cancer, diabetes, or osteoporosis.
* Are being treated for herpes at study entry.
* Have received certain medications, including blood pressure medication.
* Are pregnant or breast-feeding.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Wallis R
Role: STUDY_CHAIR
Jacobson J
Role: STUDY_CHAIR
Kalayjian R
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Queens Med Ctr
Honolulu, Hawaii, United States
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Med Ctr
Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Wallis RS, Kalayjian R, Jacobson JM, Fox L, Purdue L, Shikuma CM, Arakaki R, Snyder S, Coombs RW, Bosch RJ, Spritzler J, Chernoff M, Aga E, Myers L, Schock B, Lederman MM. A study of the immunology, virology, and safety of prednisone in HIV-1-infected subjects with CD4 cell counts of 200 to 700 mm(-3). J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):281-6. doi: 10.1097/00126334-200303010-00006.
Other Identifiers
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ACTG 349
Identifier Type: -
Identifier Source: org_study_id
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