A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease

The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system.

Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is increasing data on the potential for inhibition of immune activation as primary therapy for HIV infection. The rationale of CsA therapy is to decrease T cell activation in patients with early HIV infection. Activation of T cells leads to translation and transcription of provirus, release of viral progeny, and ultimately cell death. T cell activation also leads to increased cell death via apoptosis. CsA is capable of inhibiting both these events and thus may lead to decreased CD4 cell turnover.

This study has 2 arms of 15 patients each. Patients in Arm I receive placebo. Patients in Arm II receive CsA. Each arm is further divided into 2 strata. Stratum 1 patients are not allowed to receive antiretroviral therapy. Stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations:

  1. Zidovudine (ZDV) plus lamivudine (3TC)
  2. ZDV plus didanosine (ddI)
  3. Stavudine (d4T) plus 3TC
  4. d4T plus ddI.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard (Massachusetts Gen Hosp)
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ
    • Texas
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a CD4 count greater than or equal to 500/mm3.
  • Have a plasma HIV RNA level greater than 600 copies/ml.
  • Are over 18 years of age.
  • Agree to practice abstinence or use barrier methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have a history of an AIDS-defining illness, autoimmune disease, or hypertension.
  • Have renal disease.
  • Have any active infection other than HIV.
  • Have used certain antiretroviral medications.
  • Are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: L Calabrese
  • Study Chair: M Lederman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 334
  • 11306 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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