Status:
COMPLETED
The Effects of Prednisone on HIV Levels and the Immune System
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 r...
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 ...
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.
Key Trial Info
Start Date :
August 1 1996
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00000921
Start Date
August 1 1996
Last Update
February 23 2011
Active Locations (18)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
3
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
4
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, United States, 96816