A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection
Prednisone
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: August 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.118 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsUniv of Southern California / LA County USC Med Ctr
Los Angeles, United StatesQueens Med Ctr
Honolulu, United StatesUniv of Hawaii / Leahi Hosp
Honolulu, United States