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The virologic, immunologic, and clinical effects of interleukin 2 with potent antiretroviral therapy in patients with moderately advanced human immunodeficiency virus infection: a randomized controlled clinical trial--AIDS Clinical Trials Group 328.
Arch Intern Med. 2007 Mar 26; 167(6):597-605.AI

Abstract

BACKGROUND

Interleukin 2 (IL-2) administration increases CD4 counts in persons with higher counts. This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy (HAART).

METHODS

Two hundred four patients with CD4 T-cell counts from 50/microL to 350/microL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen. Virologic responders (< or =5000 copies/mL) at 12 weeks were randomized to open-label continuous-infusion IL-2 (IV IL-2), subcutaneous IL-2 (SC IL-2), or HAART alone. Thirty were not randomized and 15 enrolled in a substudy, leaving 159 for analysis. Subjects continued HAART alone for 72 weeks (n = 52) or with IV IL-2 (n = 53) or SC IL-2 (n = 54) for 5 days every 8 weeks. The IV IL-2 subjects could switch to SC IL-2 if their CD4 T-cell count increased by 100/microL or by 25%.

RESULTS

Patients receiving IV or SC IL-2 had greater increases in CD4 cell counts. At week 84, median increases were 459/microL, 312/microL, and 102/microL. Increases of greater than 50% at week 60 (primary end point) were achieved in 39 patients (81%) and 32 (67%) in the IV and SC IL-2 arms, respectively, compared with 13 (29%) in the HAART arm (P<.001 for both). Treatment with IL-2 did not increase plasma human immunodeficiency virus RNA levels. There were fewer new AIDS-defining events in the IV (P = .006) and SC (P = .03) IL-2 groups than in the HAART group (0, 1, and 7, respectively). Drug-related adverse events were more frequent with IL-2 treatment.

CONCLUSION

Addition of IL-2 to HAART can significantly expand CD4 T-cell counts in moderately advanced human immunodeficiency virus infection, without loss of virologic control.

Authors+Show Affiliations

Department of Internal Medicine, University of California-Los Angeles, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

17389292

Citation

Mitsuyasu, Ronald, et al. "The Virologic, Immunologic, and Clinical Effects of Interleukin 2 With Potent Antiretroviral Therapy in Patients With Moderately Advanced Human Immunodeficiency Virus Infection: a Randomized Controlled Clinical trial--AIDS Clinical Trials Group 328." Archives of Internal Medicine, vol. 167, no. 6, 2007, pp. 597-605.
Mitsuyasu R, Gelman R, Cherng DW, et al. The virologic, immunologic, and clinical effects of interleukin 2 with potent antiretroviral therapy in patients with moderately advanced human immunodeficiency virus infection: a randomized controlled clinical trial--AIDS Clinical Trials Group 328. Arch Intern Med. 2007;167(6):597-605.
Mitsuyasu, R., Gelman, R., Cherng, D. W., Landay, A., Fahey, J., Reichman, R., Erice, A., Bucy, R. P., Kilby, J. M., Lederman, M. M., Hamilton, C. D., Lertora, J., White, B. L., Tebas, P., Duliege, A. M., & Pollard, R. B. (2007). The virologic, immunologic, and clinical effects of interleukin 2 with potent antiretroviral therapy in patients with moderately advanced human immunodeficiency virus infection: a randomized controlled clinical trial--AIDS Clinical Trials Group 328. Archives of Internal Medicine, 167(6), 597-605.
Mitsuyasu R, et al. The Virologic, Immunologic, and Clinical Effects of Interleukin 2 With Potent Antiretroviral Therapy in Patients With Moderately Advanced Human Immunodeficiency Virus Infection: a Randomized Controlled Clinical trial--AIDS Clinical Trials Group 328. Arch Intern Med. 2007 Mar 26;167(6):597-605. PubMed PMID: 17389292.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The virologic, immunologic, and clinical effects of interleukin 2 with potent antiretroviral therapy in patients with moderately advanced human immunodeficiency virus infection: a randomized controlled clinical trial--AIDS Clinical Trials Group 328. AU - Mitsuyasu,Ronald, AU - Gelman,Rebecca, AU - Cherng,Deborah Weng, AU - Landay,Alan, AU - Fahey,John, AU - Reichman,Richard, AU - Erice,Alejo, AU - Bucy,R Pat, AU - Kilby,J Michael, AU - Lederman,Michael M, AU - Hamilton,Carol D, AU - Lertora,Juan, AU - White,Becky L, AU - Tebas,Pablo, AU - Duliege,Anne-Marie, AU - Pollard,Richard B, AU - ,, PY - 2007/3/29/pubmed PY - 2007/5/2/medline PY - 2007/3/29/entrez SP - 597 EP - 605 JF - Archives of internal medicine JO - Arch Intern Med VL - 167 IS - 6 N2 - BACKGROUND: Interleukin 2 (IL-2) administration increases CD4 counts in persons with higher counts. This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy (HAART). METHODS: Two hundred four patients with CD4 T-cell counts from 50/microL to 350/microL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen. Virologic responders (< or =5000 copies/mL) at 12 weeks were randomized to open-label continuous-infusion IL-2 (IV IL-2), subcutaneous IL-2 (SC IL-2), or HAART alone. Thirty were not randomized and 15 enrolled in a substudy, leaving 159 for analysis. Subjects continued HAART alone for 72 weeks (n = 52) or with IV IL-2 (n = 53) or SC IL-2 (n = 54) for 5 days every 8 weeks. The IV IL-2 subjects could switch to SC IL-2 if their CD4 T-cell count increased by 100/microL or by 25%. RESULTS: Patients receiving IV or SC IL-2 had greater increases in CD4 cell counts. At week 84, median increases were 459/microL, 312/microL, and 102/microL. Increases of greater than 50% at week 60 (primary end point) were achieved in 39 patients (81%) and 32 (67%) in the IV and SC IL-2 arms, respectively, compared with 13 (29%) in the HAART arm (P<.001 for both). Treatment with IL-2 did not increase plasma human immunodeficiency virus RNA levels. There were fewer new AIDS-defining events in the IV (P = .006) and SC (P = .03) IL-2 groups than in the HAART group (0, 1, and 7, respectively). Drug-related adverse events were more frequent with IL-2 treatment. CONCLUSION: Addition of IL-2 to HAART can significantly expand CD4 T-cell counts in moderately advanced human immunodeficiency virus infection, without loss of virologic control. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/17389292/The_virologic_immunologic_and_clinical_effects_of_interleukin_2_with_potent_antiretroviral_therapy_in_patients_with_moderately_advanced_human_immunodeficiency_virus_infection:_a_randomized_controlled_clinical_trial__AIDS_Clinical_Trials_Group_328_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinte.167.6.597 DB - PRIME DP - Unbound Medicine ER -