The Effects of Prednisone on HIV Levels and the Immune System

HIV Infections Clinical Trial

Official title:

A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000921
• Other study ID #: ACTG 349
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: February 22, 2011
• Start date: August 1996

Study information

• Verified date: June 2003
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Prednisone

Locations

Country	Name	City	State
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts
United States	Cook County Hosp	Chicago	Illinois
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	MetroHealth Med Ctr	Cleveland	Ohio
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	Milton S Hershey Med Ctr	Hershey	Pennsylvania
United States	Queens Med Ctr	Honolulu	Hawaii
United States	Univ of Hawaii	Honolulu	Hawaii
United States	Univ of Hawaii / Leahi Hosp	Honolulu	Hawaii
United States	Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Univ of Minnesota	Minneapolis	Minnesota
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Univ of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

External Links

•   Haga clic aquí para ver información sobre este ensayo clínico en español.