Phase 2
Completed N=267
Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Source: ClinicalTrials.gov NCT00110812 ↗Enrolled (actual)
267
Serious AEs
5.6%
Results posted
May 2014
Primary outcomePrimary: Mean Change in CD4+ T Lymphocyte Count — -21.8; 113.7; 110.4 cell/mm^3 — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in CD4+ T Lymphocyte Count |
-21.8; 113.7; 110.4 | <.001 sig |
| SECONDARY Discontinuation of IL-2 |
12; 32 | — |
| SECONDARY Plasma HIV RNA |
-.39; -.07; -.01 | .01 sig |
| SECONDARY Change in CD4 T Lymphocyte Count |
-8.4; 59.0; 49.8 | .009 sig |
| SECONDARY HIV-1 Genotype Changes |
2 | — |
| SECONDARY Fasting Lipid Profile |
173.4; 167.0; 164.6 | — |
| SECONDARY Disease Progression or Death |
1; 5; 7 | .14 |
| SECONDARY Initiation of Continuous ART |
34; 23; 14 | .048 sig |
| SECONDARY Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12 |
-0.64; -0.28; -0.09 | .03 sig |
| SECONDARY Thyroid Stimulating Hormone |
3; 2; 7 | — |
| SECONDARY SGOT |
1; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00110812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.