Interruption of Antiretroviral Treatment in HIV-Infected Patients with Preserved Immune Function Is Associated with a Low Rate of Clinical Progression: A Prospective Study by AIDS Clinical Trials Group 5170

• Published in: The Journal of infectious diseases 2007-05, Vol.195 (10), p.1426-1436
• Main Authors: Skiest, Daniel J., Zhaohui Su, Havlir, Diane V., Robertson, Kevin R., Coombs, Robert W., Cain, Pat, Peterson, Tianna, Krambrink, Amy, Jahed, Nasreen, McMahon, Deborah, Margolis, David M.
• Format: Article
• Language: English
• Subjects: Acquired Immunodeficiency Syndrome - drug therapy; Acquired Immunodeficiency Syndrome - immunology; Acquired Immunodeficiency Syndrome - mortality; Adult; AIDS; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Anti-Retroviral Agents - therapeutic use; Antiretrovirals; Art therapy; Arts; Biological and medical sciences; CD4 Lymphocyte Count; Clinical trials; Disease Progression; Female; Fundamental and applied biological sciences. Psychology; Grants; HIV; HIV infections; HIV/AIDS; Human immunodeficiency virus; Human viral diseases; Humans; Infectious diseases; Male; Medical sciences; Microbiology; Middle Aged; Monitoring, Physiologic; Nadir; Patient Selection; Prospective Studies; Survival Analysis; T lymphocytes; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/512681

Background. We sought to determine the safety of treatment interruption (TI) and to identify parameters that would define patients with human immunodeficiency virus (HIV) for whom TI is safer. Methods. AIDS Clinical Trials Group 5170 was a multicenter, 96-week-long, prospective study of HIV-infected patients receiving antiretroviral therapy (ART) who had CD4⁺ cell counts >350 cells/mm³ and who underwent TI. Results. A total of 167 patients were enrolled. The median nadir in CD4⁺ cell count was 436 cells/mm³. The initial decrease (i.e., during the first 8 weeks) in CD4⁺ cell count after ART interruption was 20 cells/mm³/week; the subsequent decrease was 2.0 cells/mm³/week until week 96. Both the CD4⁺ cell count before enrollment and the increase in CD4⁺ cell count during ART predicted early decrease; later decrease was predicted by the level of interleukin7 at enrollment. A Centers for Disease Control and Prevention (CDC) diagnosis of a category B or C event was made for 2 and 2 patients, respectively (all had CD4⁺ cell counts >350 cells/mm³). At week 96, 17 patients had CD4⁺ cell counts ⩽250 cells/mm³, and 46 patients had resumed ART; 5 patients died (unrelated to HIV or acquired immunodeficiency syndrome). In a multivariate analysis, a higher nadir in CD4⁺ cell count (>400 cells/mm³), a lower HIV load (