AldesleukinOther Names: IL-2, Proleukin, interleukin-2, rIL-2, recombinant human interleukin-2, recombinant interleukin-2, rhIL-2 Drug Class: Immune Modulators Molecular Formula: C690 H1115 N177 O203 S6 Chemical Name: 2-133-Interleukin 2 (human reduced), 125-L-serine- Chemical Class: Recombinant interleukin Organization: Novartis Vaccines and Diagnostics, Inc. Phase of Development: Aldesleukin is in Phase 3 development as an immune modulator for HIV infection.
(Compound details obtained from ChemIDplus Advanced,1 Journal of Internal Medicine article,2 DailyMed Proleukin Full Prescribing Information,3 and ClinicalTrials.gov4,5)
What is aldesleukin?
Aldesleukin (brand name: Proleukin) is a drug that has been approved by the U.S.(FDA) to treat two types of cancers: cell carcinoma and melanoma.3 It is also being studied as an to treat HIV .
As an investigational HIV drug, aldesleukin belongs to a group of HIV drugs called.2 Immune modulators (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function.
Aldesleukin is a synthetic version of, which is a that is made naturally in the body. Interleukin-2 helps activate the to make more immune cells and stimulates existing immune cells to fight infections, such as HIV infection.3,6
Which clinical trials are studying aldesleukin?
Study Name: NCT03308786
Status: This study is currently recruiting participants.
Location: United States
Purpose: The purpose of this study is to see whether aldesleukin can decrease the number of resting CD4 cells within the and reduce the size of the reservoir in individuals with .7
Study Names: ANRS118; ILIADE; NCT00071890
Status: This study has been completed.
Location: United States and France
Purpose: The purpose of this study was to see whether aldesleukin given before a planned interruption of (ART) could extend the time that participants are temporarily off treatment and also keep their CD4 counts above 350 cells/mm3.8
Study Names: ESPRIT; NCT00004978
Status: This study has been completed.
Location: Multiple countries, including the United States
Purpose: The purpose of this study was to evaluate whether aldesleukin plus ART could lower the risk of and death in participants with HIV.4,9
Study Names: SILCAAT; NCT00013611
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate whether aldesleukin plus ART could lower the risk of opportunistic infection and death in participants with HIV.5,9
For more details on the studies listed above, see the Health Professional version of this drug summary.
A number of other HIV-related studies on aldesleukin have been conducted, including:
- The STALWART study (NCT00110812), a Phase 2 study which looked at the effects of aldesleukin with and without ART on CD4 counts in participants who were either off ART or who had never taken ART before. This study has been completed.10
- The ANRS 119 study (NCT00120185), a Phase 2 study which evaluated whether aldesleukin without ART could increase CD4 counts and delay the need to start ART in participants who were either off ART or who had never taken ART before. This study has been completed.11,12
- The COSMIC study, which looked at the effects of aldesleukin with and without ART on the latent HIV reservoir. This study has been completed.13
- NCT01013415 is a Phase 1/2 study that is currently evaluating a combination HIV cure approach using aldesleukin in combination with another investigational treatment. This study is ongoing, but not recruiting participants.14
- NCT03346499 is a Phase 2 study that evaluated an of natural killer cells and aldesleukin in people on ART with viral suppression. This study has been completed.15
What side effects might aldesleukin cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of aldesleukin listed above.
ANRS118; ILIADE (NCT00071890):
Many mild to moderate side effects associated with aldesleukin occurred in the first 24 weeks of the study. The most common side effects were weakness, fever, and nausea. Eleven participants receiving aldesleukin stopped the study early because of side effects related to aldesleukin. Overall, the few severe side effects that occurred during the study occurred more frequently in the aldesleukin group than in the ART-only group.16
ESPRIT (NCT00004978) and SILCAAT (NCT00013611):
In these studies, serious side effects were more common in participants who received aldesleukin plus ART than in participants who received ART alone. Serious side effects that occurred in either the ESPRIT study or the SILCAAT study included heart and blood vessel disorders, disorders, and psychiatric disorders.9
Because aldesleukin is still being studied in people with HIV, information on possible side effects of the drug is not complete. As testing of aldesleukin continues, additional information on possible side effects will be gathered.
Additional information on side effects that are known to be associated with aldesleukin can be found in the FDA-approved Full Prescribing Information for Proleukin.
Where can I get more information about clinical trials studying aldesleukin?
More information about aldesleukin-related research studies is available from the AIDSinfo database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a NIH Clinical Research Trials and You.is right for you. For more information, visit
- United States National Library of Medicine. ChemIDplus Advanced: Aldesleukin. https://chem.nlm.nih.gov/chemidplus/rn/110942-02-4. Accessed September 27, 2019
- Gougeon M, Chiodi F. Impact of γ-chain cytokines on T cell homeostasis in HIV-1 infection: therapeutic implications. J Intern Med. 2010;(267):502-514.
- Prometheus Laboratories Inc. Proleukin: full prescribing information, May 23, 2019. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e2b687e-47f2-4f3c-80ab-e3224befffca. Accessed September 27, 2019
- National Institute of Allergy and Infectious Diseases (NIAID). A randomized, open-label, Phase III, international study of subcutaneous recombinant IL-2 in patients with HIV-1 infection and CD4+ cell counts 300/mm^3 or greater: evaluation of subcutaneous proleukin in a randomized international trial. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 10, 2000. NLM Identifier: NCT00004978. https://clinicaltrials.gov/ct2/show/NCT00004978. Accessed September 27, 2019
- University of Minnesota - Clinical and Translational Science Institute. A Phase III multicenter randomized study of the biological and clinical efficacy of subcutaneous recombinant, human interleukin-2 in HIV-infected patients with low CD4+ counts under active antiretroviral therapy (SILCAAT Amendment 4). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 24, 2001. NLM Identifier: NCT00013611. https://clinicaltrials.gov/ct2/show/NCT00013611. Accessed September 27, 2019
- Paredes R, López Benaldo de Quirós J, Fernández-Cruz E, Clotet B, Lane H. The potential role of interleukin-2 in patients with HIV infection. AIDS Rev. 2002;4(1):36-40.
- Case Western Reserve University. HIV reservoir reduction with interleukin-2. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 29, 2017. NLM Identifier: NCT03308786. https://clinicaltrials.gov/ct2/show/NCT03308786. Accessed September 27, 2019
- National Institute of Allergy and Infectious Diseases (NIAID). Phase II/III study evaluating the effect of IL-2 on preservation of the CD4 T-lymphocytes after interruption of anti-retroviral tx in HIV infected patients with CD4 T-lymphocyte count greater than 500 cells/mm(3) who have received anti-retroviral tx. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 3, 2003. NLM Identifier: NCT00071890. https://clinicaltrials.gov/ct2/show/NCT00071890. Accessed September 27, 2019
- Abrams D, Lévy Y, Losso M, et al. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009;361(16):1548-1559.
- National Institute of Allergy and Infectious Diseases (NIAID). STALWART: a randomized, open-label, international study of subcutaneous recombinant interleukin-2 with and without concomitant antiretroviral therapy in patients with HIV-1 infection and CD4+ cell counts of 300 cells/mm3 or more. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 13, 2005. NLM Identifier: NCT00110812. https://clinicaltrials.gov/ct2/show/NCT00110812. Accessed September 27, 2019
- Molina J-M, Levy Y, Fournier I, et al. Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119). J Infect Dis. 2009;200(2):206–215.
- French National Agency for Research on AIDS and Viral Hepatitis. Study of the immunological efficacy of using subcutaneous interleukin-2 (IL-2) in antiretroviral naive HIV-1-infected subjects with a CD4 cell count above 300/mm3. ANRS 119 Trial INTERSTART. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 8, 2005. NLM Identifier: NCT00120185. https://clinicaltrials.gov/ct2/show/NCT00120185. Accessed September 27, 2019
- Stellbrink H-J, van Lunzen J, Westby M, et al. Effects of interleukin-2 plus highly active antiretroviral therapy on HIV-1 replication and proviral DNA (COSMIC trial). AIDS. 2002;16(11):1479-1487.
- University of Pennsylvania. A Phase I/II study of the safety, survival, and trafficking of autologous CD4-ZETA gene-modified T cells with and without extension interleukin-2 in HIV infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 5, 2009. NLM Identifier: NCT01013415. https://clinicaltrials.gov/ct2/show/NCT01013415. Accessed September 27, 2019
- University of Minnesota - Clinical and Translational Science Institute. Adoptive transfer of haploidentical natural killer cells and IL-2 in human immunodeficiency virus (HIV). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 24, 2017. NLM Identifier: NCT03346499. https://www.clinicaltrials.gov/ct2/show/NCT03346499. Accessed September 27, 2019
- Lévy Y, Thiébaut R, Gougeon M-L, et al. Effect of intermittent interleukin-2 therapy on CD4+ T-cell counts following antiretroviral cessation in patients with HIV. AIDS. 2012;26(6):711.
Last Reviewed: September 27, 2019
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