Status:
COMPLETED
Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Chiron Corporation
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Th...
Detailed Description
Highly active antiretroviral therapy (HAART) has dramatically improved prognosis and lowered morbidity and mortality rates for HIV infected patients. However, significant drug toxicities, difficulties...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00110812
Start Date
September 1 2005
End Date
February 1 2011
Last Update
November 4 2021
Active Locations (36)
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1
VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS
Los Angeles, California, United States, 90073
2
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, United States, 20422
3
NIH Clinical Ctr., NIAID HIV Clinic CRS
Bethesda, Maryland, United States, 20814-9692
4
Henry Ford Hosp. CRS
Detroit, Michigan, United States, 48202