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Home > "T" Clinical Trials Conditions > The Effects of Prednisone on HIV Levels and the Immune System  The Effects of Prednisone on HIV Levels and the Immune System
The Effects of Prednisone on HIV Levels and the Immune System
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 118
Location and Contact Information:
Overall Study Official:
WallisR, Study Chair,
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, 96816
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Washington
Seattle, Washington, 98104
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Additional Information:
Study ID Numbers: ACTG 349;
Study Start Date: August 1996
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000921
Other Hiv Infections Studies:
1. A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
2. A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
3. A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
4. Heterosexual HIV Transmission Study (HATS)
5. A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
Related Studies:
Other HIV Infections Clinical Trials
Other Hawaii Clinical Trials
Other Honolulu Clinical Trials
The Effects of Prednisone on HIV Levels and the Immune System
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