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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Page 1 of 5 (18 locations)

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