Search / Trial NCT00000880

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 09, 2024

Completed

Keywords

T Lymphocytes Lymphocyte Transformation Hiv 1 Drug Therapy, Combination Immunosuppressive Agents Apoptosis Cyclosporine Anti Hiv Agents

ClinConnect Summary

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 i...

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

L Calabrese

Study Chair

M Lederman

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

New York, New York, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Cleveland, Ohio, United States

Baltimore, Maryland, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Galveston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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