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

• Status: Completed
• Trial end date: 2000-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Cyclosporine; Cyclosporins

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.