Immunological and virological responses in HIV-1-infected adults at early stage of established infection treated with highly active antiretroviral therapy

Objective: To evaluate the immunological and virological responses ro highl y active antiretroviral therapy (HAART) in blood and lymphoid compartments of HIV-1-infected patients at an early stage of infection. Design: An open-label, observational, non-randomized, prospective trial of outpatients attending the Centre of Clinical Investigation in Infectious Di seases, Centre Hospitalier Universitaire Vaudois, University of Lausanne, S witzerland. Subjects: Forty-one antiretroviral-naive HIV-l-infected adults with 400 CD4 T cells/mu l or greater and 5000 plasma HIV-1-RNA copies/ml or greater wer e enrolled, and 32 finished the study. Forty-nine HIV-negative individuals were included as controls. All subjects gave written informed consent. Interventions: All patients received abacavir 300 mg by mouth every 12 h an d amprenavir 1200 mg by mouth every 12 h for 72 weeks. Mainoutcome measures: The extent of immune reconstitution in blood and lymp h nodes after 72 weeks of HAART was evaluated, and compared with immunologi cal measures of 49 HIV-negative subjects. Results: Virus replication was effectively suppressed (-3.5 log(10) at week 72). Substantial increments of CD4 T cell count in blood and percentage in lymph nodes were observed over time, and these measures were comparable to HIV-negative subjects by week 24 in blood and by week 48 in lymph nodes. T he increase was equally distributed between naive and memory CD4 T cells. R ecovery of HIV-specific CD4 responses occurred in 40% of patients. Conclusion: The initiation of HAART at an early stage of established HIV in fection induces systemic quantitative normalization of CD4 T cells, a parti al recovery of HIV-specific CD4 cell responses, and effective and durable s uppression of virus replication. (C) 2000 Lippincott Williams & Wilkins.