title: Long-cycle structured intermittent versus continuous highly active antiretroviral therapy for the treatment of chronic infection with human immunodeficiency virus: effects on drug toxicity and on immunologic and virologic parameters.
abstract: We evaluated the effect of long-cycle structured intermittent therapy (SIT; 4 weeks without highly active antiretroviral therapy [HAART] followed by 8 weeks with HAART) versus continuous HAART. The study was prematurely terminated to new enrollment because of the emergence of genetic mutations associated with resistance to antiretroviral drugs in 5 patients. After 48 weeks, there was no significant difference between groups in lipid, hepatic transaminase, and C-reactive protein levels in 41 patients. Although there were no differences in CD4(+) or CD8(+) T cell counts or the percentage of cells that were CD4(+)CD25(+), CD8(+)CD25(+), or CD4(+)DR(+), patients who received SIT had a significantly higher percentage of CD8(+)CD38(+) and CD8(+)DR(+) cells. There was no clear autoimmunization effect by immunologic or virologic parameters. There was no benefit to long-cycle SIT versus continuous HAART with regard to certain toxicity, immunologic, or virologic parameters.
authors.affiliation: Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA. mdybul@nih.gov.
authors.forename: Mark
authors.initials: M
authors.lastname: Dybul
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Nies-Kraske
authors.forename: Marybeth
authors.initials: M
authors.lastname: Daucher
authors.forename: Kurt
authors.initials: K
authors.lastname: Hertogs
authors.forename: Claire W
authors.initials: CW
authors.lastname: Hallahan
authors.forename: Gyorgy
authors.initials: G
authors.lastname: Csako
authors.forename: Christian
authors.initials: C
authors.lastname: Yoder
authors.forename: Linda
authors.initials: L
authors.lastname: Ehler
authors.forename: Peter A
authors.initials: PA
authors.lastname: Sklar
authors.forename: Michael
authors.initials: M
authors.lastname: Belson
authors.forename: Bertha
authors.initials: B
authors.lastname: Hidalgo
authors.forename: Julia A
authors.initials: JA
authors.lastname: Metcalf
authors.forename: Richard T
authors.initials: RT
authors.lastname: Davey
authors.forename: Diane M
authors.initials: DM
authors.lastname: Rock Kress
authors.forename: April
authors.initials: A
authors.lastname: Powers
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Fauci
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000626:Aminopeptidases / Q000097:blood; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D002097:C-Reactive Protein / Q000032:analysis; D016516:CD4-CD8 Ratio; D004334:Drug Administration Schedule; D024882:Drug Resistance, Viral; D005500:Follow-Up Studies; D043384:Glutamyl Aminopeptidase; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008055:Lipids / Q000097:blood; D018655:Lymphocyte Count; D012367:RNA, Viral / Q000032:analysis; D015375:Receptors, Interleukin-2 / Q000032:analysis; D013601:T-Lymphocytes / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D012367:RNA, Viral; D015375:Receptors, Interleukin-2; D002097:C-Reactive Protein; D000410:Alanine Transaminase; D000626:Aminopeptidases; D043384:Glutamyl Aminopeptidase