The Effects of Prednisone on HIV Levels and the Immune System

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00000921

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

118

Starts

1996-08-01

Last updated by the study team

2011-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii / Leahi Hosp — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• MetroHealth Med Ctr — Cleveland, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Milton S Hershey Med Ctr — Hershey, Pennsylvania, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.