The Effects of Prednisone on HIV Levels and the Immune System
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Prednisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Wallis R, Study Chair
Jacobson J, Study Chair
Kalayjian R, Study Chair
Summary
The purpose of this study is to see if it is safe and effective to give prednisone to
HIV-infected patients.
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).
Clinical Details
Official title: A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection
Study design: Treatment, Double-Blind, Safety Study
Detailed description:
By inhibiting cellular activation, corticosteroids such as prednisone may inhibit HIV
expression and reduce the population of potentially infectable cells. Furthermore, no studies
have been performed to systematically evaluate immune function in prednisone-treated,
HIV-infected patients or the immune mechanisms that may facilitate increases in CD4+ cell
number. This study explores this issue.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
You may be eligible for this study if you:
- 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
You will not be eligible for this study if you:
- 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.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California 900331079, United States
Queens Med Ctr, Honolulu, Hawaii 96816, United States
Univ of Hawaii, Honolulu, Hawaii 96816, United States
Univ of Hawaii / Leahi Hosp, Honolulu, Hawaii 96816, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts 02114, United States
Univ of Minnesota, Minneapolis, Minnesota 55455, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Case Western Reserve Univ, Cleveland, Ohio 44106, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
MetroHealth Med Ctr, Cleveland, Ohio 441091998, United States
Milton S Hershey Med Ctr, Hershey, Pennsylvania 170330850, United States
Univ of Washington, Seattle, Washington 98104, United States
Additional Information
Haga clic aquí para ver información sobre este ensayo clínico en español.
Related publications: 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.
Starting date: August 1996
Last updated: June 23, 2005
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