Four drug-HAART in primary HIV-1 infection: clinical benefits and virologic parameters

Background: From a theoretical standpoint, primary HIV infection (PHI) repr esents a great chance to modify the natural history of the disease. In this study we purposed a four drugs regimen with zidovudine, lamivudine, ritona vir and saquinavir to treat aggressively the infection and achieve a comple te immune reconstitution. Methods: This is an Italian multicentric open label study. Adult patients w ith PHI were eligible for the study if they met at least one clinical crite rion and one laboratory criterion of the following. Clinical criteria: Sign s and symptoms of acute retroviral syndrome within the past 70 days, exposu re to HIV-1 within the last 3 months, a preceding negative antibody test wi thin the past 6 months. Laboratory criteria: Detectable p24 antigen with ne utralization 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 enro lled; 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 Treatment has been withdrawn in 17 patients (12 for intolerance, 3 for toxicity and 2 for failure).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 a nd 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 pati ents at week 12, 81% at week 24, 93% after 12 months and 100% after 18 mont hs. Immunological parameters have been improved and have achieved normal ra nge since 6(th) month. Conclusions: A rapid virologic suppression and immunological reconstitution are associated with PHI therapy. However early treatment should be weighte d against the potential disadvantages such as immediate adverse events (int olerance and drug toxicity) and long term manifestation (metabolic disorder s).