Overview

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