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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Chiron Corporation
• Treatments: Aldesleukin; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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