Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.

Key facts

Study ID

NCT00110812

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

267

Starts

2005-09-01

Expected to finish

2011-02-01

Last updated by the study team

2021-11-04

Who can join

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

You may qualify if…

• HIV infected
• CD4 count of 300 cells/mm3 or more
• Access to a HAART regimen consisting of 1 or more protease inhibitors (PIs) and 2 or more nucleoside or nucleotide reverse transcriptase inhibitors

You may not qualify if…

• Prior use of aldesleukin
• Approved or experimental antiretroviral drug (including hydroxyurea) within 1 year prior to study entry
• Evidence of virologic failure on a PI- or nonnucleoside-based HAART regimen
• Any current indication for continuous HAART, in the opinion of the investigator
• Any contraindication to HAART, in the opinion of the investigator
• Systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 45 days of randomization
• Approved or experimental agents with clinically significant immunomodulatory effects within 8 weeks prior to randomization
• History of any AIDS-defining illness or certain other diseases. More information on this criterion can be found in the protocol.
• Concurrent cancer requiring cytotoxic therapy
• Any central nervous system (CNS) abnormality requiring ongoing treatment with antiseizure medication
• Current or prior autoimmune or inflammatory diseases, including inflammatory bowel disease, psoriasis, optic neuritis, or any other autoimmune or inflammatory diseases with potentially life-threatening complications
• Significant heart, lung, kidney, liver, gastrointestinal, CNS, or psychiatric disease OR illicit substance use or abuse that, in the opinion of the investigator, would interfere with the study
• Pregnancy or breastfeeding

Where it is running

• VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS — Los Angeles, California, United States
• Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS — Washington D.C., District of Columbia, United States
• NIH Clinical Ctr., NIAID HIV Clinic CRS — Bethesda, Maryland, United States
• Henry Ford Hosp. CRS — Detroit, Michigan, United States
• Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) — New York, New York, United States
• Lincoln Hosp. & Med. Ctr. CRS — The Bronx, New York, United States
• Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS — Portland, Oregon, United States
• Michael E. DeBakey VAMC CRS — Houston, Texas, United States
• Thomas Street Clinic CRS — Houston, Texas, United States
• South Texas Veterans Health Care System, Immunosuppression Clinic CRS — San Antonio, Texas, United States
• Virginia Commonwealth Univ. Medical Ctr. CRS — Richmond, Virginia, United States
• Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Funcei Crs — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Caici Crs — Rosario, Provincia de Sante Fe, Argentina
• St. Vincent's Hospital CRS — Darlinghurst, New South Wales, Australia
• Queensland Health - AIDS Med. Unit CRS — Brisbane, Queensland, Australia
• Gladstone Road Medical Ctr. CRS — Highgate Hill, Queensland, Australia
• Gold Coast Sexual Health Clinic CRS — Miami, Queensland, Australia
• Carlton Clinic CRS — Carlton, Victoria, Australia
• Fundacion Arriaran CRS — Santiago, Chile
• Ospedale San Raffaele S.r.l. CRS — Milan, Italy
• Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS — Milan, Italy
• Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS — Casablanca, Morocco
• Wojewodzki Szpital Zakazny CRS — Warsaw, Poland

Full record on ClinicalTrials.gov

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