Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. The purpose of this study is to find out if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for short periods of time can help patients control their HIV viral load.

Study hypothesis: Patients in this study will have lower virologic rebound and will maintain their CD4 cell counts for a longer time than other patients in comparative studies.

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

Details

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

Criteria

Note: ACTG A5132 closed to accrual on 11/01/04.

Inclusion Criteria:

• HIV infected

• CD4 cell count of 300 cells/mm3 or more within 30 days prior to study entry

• HIV viral load of less than 50 copies/ml within 30 days prior to study entry

• Anti-HIV drug regimen of at least 3 anti-HIV drugs for at least 6 months immediately prior to study entry

• Documented pretherapy plasma HIV viral load measured within 6 months of starting ART

• Willing to use acceptable methods of contraception

Exclusion Criteria:

• HIV viral load of 50 copies/ml or more within 60 days before study entry

• Current use of experimental anti-HIV drugs other than FDA sanctioned investigational drugs

• Abacavir as part of anti-HIV regimen within 8 weeks prior to study entry

• Pregnant or breastfeeding

• History of autoimmune disease, except for stable autoimmune thyroid disease

• Heart problems or on certain medications for treatment of heart problems

• Cancer requiring chemotherapy

• Untreated thyroid disease

• Disease of the central nervous system that has been active within 1 year prior to study entry

• Uncontrolled diabetes

• Allergies to the study medications

• Other illnesses that would make it inappropriate for patients to participate in the study

• Immunomodulatory therapy within 4 weeks prior to study entry

• Hydroxyurea within 6 months prior to study entry

• Drug or alcohol use that, in the opinion of the investigator, would interfere with the study

• Psychiatric or mental impairment that would affect compliance