Effect of Interleukin-2 on HIV Treatment Interruption

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Interleukin-2 (IL-2) helps the body make infection-fighting white blood cells, including CD4 and CD8 T cells. One HIV treatment strategy is planned treatment interruption (stopping anti-HIV drugs when CD4 count and level of virus in the blood are at certain levels). The purpose of this study is to see if IL-2 used with potent anti-HIV drugs allows for longer HIV treatment interruptions.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria:

• HIV infected

• On stable, potent ART regimen for at least 3 months prior to study entry

• Viral load of less than 400 copies/ml for at least 6 months prior to study entry

• Viral load of less than 200 copies/ml at screening

• CD4 count of 500 cells/mm3 or greater at screening

• Agree to use acceptable methods of contraception

• Agree to be followed on this study for at least 4 years

• Primary care provider willing to have the patient in the study and to comply with study guidelines

Exclusion Criteria:

• Active or past significant AIDS-related illness. Patients with a history of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma, pulmonary tuberculosis, or bacterial pneumonia are not excluded.

• Immunomodulators within 1 month of study entry

• Hydroxyurea within 3 months of study entry

• Prior IL-2 treatment

• Drugs to treat heart disease within 30 days of study entry

• Serious heart problems

• Cancer requiring anti-cancer drugs

• Thyroid problems. If the condition has been controlled by drugs for at least 3 months prior to study entry, the patient is not excluded.

• Uncontrolled diabetes

• Breathing or stomach problems that, in the opinion of the investigator, may affect the safety of the patient

• History of autoimmune disease, including inflammatory bowel disease, psoriasis, and optic neuritis

• Organ transplant

• History of neurological disorder or mental illness that, in the opinion of the investigator, may interfere with study requirements

• Alcohol or drug abuse that, in the opinion of the investigator, may interfere with study requirements

• Astemizole, midazolam, or triazolam within 2 weeks of study entry

• Systemic corticosteroids for 4 weeks or more within 3 months of study entry

• Pregnancy or breastfeeding