The Effects of Prednisone on HIV Levels and the Immune System
- Conditions
- HIV Infections
- Registration Number
- NCT00000921
- 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 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
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
Scroll for more (8 remaining)Univ of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States