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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000880
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Cyclosporine
Phase II

MedlinePlus related topics:   AIDS   

Drug Information available for:   Cyclosporin    Cyclosporine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   30

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000880

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

Sponsors and Collaborators

Investigators
Study Chair:     L Calabrese    
Study Chair:     M Lederman    
  More Information


Publications:

Study ID Numbers:   ACTG 334
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000880
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
T-Lymphocytes  
Lymphocyte Transformation  
HIV-1  
Drug Therapy, Combination  
Immunosuppressive Agents
Apoptosis
Cyclosporine
Anti-HIV Agents

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Cyclosporine
Clotrimazole
HIV Infections
Miconazole
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Tioconazole
Cyclosporins
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Infection
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on December 03, 2008




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