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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000921 |
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).
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection |
Estimated Enrollment: | 118 |
Study Start Date: | August 1996 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Hawaii | |
Queens Med Ctr | |
Honolulu, Hawaii, United States, 96816 | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
Univ of Hawaii / Leahi Hosp | |
Honolulu, Hawaii, United States, 96816 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 441091998 | |
United States, Pennsylvania | |
Milton S Hershey Med Ctr | |
Hershey, Pennsylvania, United States, 170330850 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | Wallis R | |
Study Chair: | Jacobson J | |
Study Chair: | Kalayjian R |
Study ID Numbers: | ACTG 349 |
Study First Received: | November 2, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000921 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Prednisone Anti-HIV Agents |
Virus Diseases Prednisone Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Inflammatory Agents Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Infection Glucocorticoids Hormones Pharmacologic Actions Therapeutic Uses Lentivirus Infections |