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

Keywords

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...

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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.