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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000880

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Expected to finish

2000-05-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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