Search / Trial NCT00000921

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 December 14, 2024

Completed

Keywords

Drug Therapy, Combination Prednisone Anti Hiv Agents

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.

Trial Officials

Wallis R

Study Chair

Jacobson J

Study Chair

Kalayjian R

Study Chair

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.

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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