title: Four drug-HAART in primary HIV-1 infection: clinical benefits and virologic parameters.
abstract: BACKGROUND
  From a theoretical standpoint, primary HIV infection (PHI) represents a great chance to modify the natural history of the disease. In this study we purposed a four drugs regimen with zidovudine, lamivudine, ritonavir and saquinavir to treat aggressively the infection and achieve a complete immune reconstitution.
  
  
  METHODS
  This is an Italian multicentric open label study. Adult patients with PHI were eligible for the study if they met at least one clinical criterion and one laboratory criterion of the following. Clinical criteria: Signs and symptoms of acute retroviral syndrome within the past 70 days, exposure to HIV-1 within the last 3 months, a preceding negative antibody test within the past 6 months. Laboratory criteria: Detectable p24 antigen with neutralization in serum; detectable HIV-RNA in plasma; indeterminate Western blot test with negative or low positive value HIV antibody in ELISA test.
  
  
  RESULTS
  Since April 1997 to April 1999 40 patients with PHI have been enrolled; 80% of this cohort referred symptoms related to acute antiretroviral syndrome. Treatment has been withdrawn in 17 patients (12 for intolerance, 3 for toxicity and 2 for failure). At baseline the mean CD4+ T cells count and CD4/CD8 ratio were 537 (range 55-1287) and 0.58 (range 0.1-1.03) and the mean plasma HIV-RNA level was 5.9 log copies/ml (range 3-7.15). Plasmatic HIV-1 RNA levels of all patients dropped below 200 copies/ml in 68% of patients at week 12, 81% at week 24, 93% after 12 months and 100% after 18 months. Immunological parameters have been improved and have achieved normal range since 6th month.
  
  
  CONCLUSIONS
  A rapid virologic suppression and immunological reconstitution are associated with PHI therapy. However early treatment should be weighted against the potential disadvantages such as immediate adverse events (intolerance and drug toxicity) and long term manifestation (metabolic disorders).
authors.affiliation: Department of Infectious Diseases, San Raffaele Scientific Institute, Milano, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Capiluppi
authors.forename: D
authors.initials: D
authors.lastname: Ciuffreda
authors.forename: G P
authors.initials: GP
authors.lastname: Quinzan
authors.forename: M
authors.initials: M
authors.lastname: Sciandra
authors.forename: M
authors.initials: M
authors.lastname: Marroni
authors.forename: B
authors.initials: B
authors.lastname: Morandini
authors.forename: P
authors.initials: P
authors.lastname: Costigliola
authors.forename: L
authors.initials: L
authors.lastname: Guerra
authors.forename: M
authors.initials: M
authors.lastname: Di Pietro
authors.forename: G F
authors.initials: GF
authors.lastname: Fibbia
authors.forename: R
authors.initials: R
authors.lastname: Visonà
authors.forename: M
authors.initials: M
authors.lastname: Cusini
authors.forename: C
authors.initials: C
authors.lastname: Bressi
authors.forename: G
authors.initials: G
authors.lastname: Tambussi
authors.forename: A
authors.initials: A
authors.lastname: Lazzarin
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio / Q000187:drug effects; D004359:Drug Therapy, Combination; D005260:Female; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D011446:Prospective Studies; D019438:Ritonavir / Q000008:administration & dosage; D019258:Saquinavir / Q000008:administration & dosage; D015215:Zidovudine / Q000008:administration & dosage
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine; D015215:Zidovudine; D019258:Saquinavir; D019438:Ritonavir