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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Last Updated

February 23, 2011

Status Verified

June 1, 2003

Enrollment Period

5.8 years

First QC Date

November 2, 1999

Last Update Submit

February 22, 2011

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationPrednisoneAnti-HIV Agents

Interventions

PrednisoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Queens Med Ctr

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii / Leahi Hosp

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, 02114, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

MetroHealth Med Ctr

Cleveland, Ohio, 441091998, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Milton S Hershey Med Ctr

Hershey, Pennsylvania, 170330850, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Wallis RS, Kalayjian R, Jacobson JM, Fox L, Purdue L, Shikuma CM, Arakaki R, Snyder S, Coombs RW, Bosch RJ, Spritzler J, Chernoff M, Aga E, Myers L, Schock B, Lederman MM. A study of the immunology, virology, and safety of prednisone in HIV-1-infected subjects with CD4 cell counts of 200 to 700 mm(-3). J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):281-6. doi: 10.1097/00126334-200303010-00006.

    PMID: 12626887BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Wallis R

    STUDY CHAIR

  • Jacobson J

    STUDY CHAIR

  • Kalayjian R

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

August 1, 1996

Primary Completion

June 1, 2002

Last Updated

February 23, 2011

Record last verified: 2003-06

Locations

US(18)