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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00038259

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

21

Expected to finish

2006-05-01

Last updated by the study team

2021-11-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• Univ. of Texas Medical Branch, ACTU — Galveston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.