Effect of Interleukin-2 on HIV Treatment Interruption

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00015704

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

80

Expected to finish

2004-11-01

Last updated by the study team

2021-11-01

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Washington U CRS — St Louis, Missouri, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. — Omaha, Nebraska, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• Cornell CRS — New York, New York, United States
• Weill Med. College of Cornell Univ., The Cornell CTU — New York, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• Pitt CRS — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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