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The Effects of Prednisone on HIV Levels and the Immune System

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000921
  Purpose

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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Prednisone   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   118
Study Start Date:   August 1996

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000921

Locations
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

Sponsors and Collaborators

Investigators
Study Chair:     Wallis R    
Study Chair:     Jacobson J    
Study Chair:     Kalayjian R    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   ACTG 349
First Received:   November 2, 1999
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00000921
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination  
Prednisone  
Anti-HIV Agents  

Study placed in the following topic categories:
Virus Diseases
Prednisone
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on December 03, 2008




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