The Effects of Prednisone on HIV Levels and the Immune System
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Los Angeles, California, United States
Indianapolis, Indiana, United States
New York, New York, United States
Columbus, Ohio, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Seattle, Washington, United States
Chicago, Illinois, United States
New York, New York, United States
Cleveland, Ohio, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Cleveland, Ohio, United States
Minneapolis, Minnesota, United States
Boston, Massachusetts, United States
Hershey, Pennsylvania, United States
Honolulu, Hawaii, United States
Patients applied
Trial Officials
Wallis R
Study Chair
Jacobson J
Study Chair
Kalayjian R
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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