Virological and immunological responses to HAART in asymptomatic therapy-naive HIV-1-infected subjects according to CD4 cell count

Objective: When to start highly active antiretroviral therapy (HAART) in as ymptomatic chronically HIV-l-infected subjects with CD4 cell counts of 300 x 10(6)-500 x 10(6)/l is debated extensively. Retrospective analyses of vir ological and immunological responses following HAART have been evaluated in both blood and lymph nodes according to pre-treatment levels of CD4 cells either above or below 500 x 10(6)/l. Design: Open-label, observational, non-randomized, prospective study. Setting: Outpatients attending the Centre of Clinical Investigation in Infe ctious Diseases, Centre Hospitalier Universitaire Vaudois, University of La usanne, Switzerland. Participants: Fifty-four HIV-l-infected antiretroviral-naive subjects with CD4 cell count greater than or equal to 250 x 10(6)/l and plasma viraemia g reater than or equal to 5000 copies/ml who had been treated with HAART for at least 48 weeks. Controls were 49 HIV-negative subjects. Interventions: All patients received abacavir, nelfinavir, saquinavir soft gel capsules, and amprenavir in varying combinations for 72 weeks. Main outcome measures: The extent of immune reconstitution following HAART in 43 and 11 subjects with either more or fewer than 500 x 10(6) CD4 cells/ l at baseline was evaluated in blood and lymph node, and compared with immu nological measures observed in 49 HIV-negative controls. Results: After 48 weeks of therapy, plasma viraemia was suppressed effectiv ely in both groups of patients. Normalization of both CD4 cell count in blo od, divided equally between memory and naive cells, and percentage of CD4 c ells in lymph nodes occurred in the two groups. Consistently, the net incre ase over baseline in CD4 cell count and in memory and naive CD4 subsets was greater in patients with fewer than 500 x 10(6) CD4 cells/l at baseline. R ecovery of HIV-specific responses was similar in the two groups. Conclusions: This study suggests that virological and immunological respons es are comparable in asymptomatic therapy-naive HIV-l-infected subjects wit h CD4 cell counts above or below 500 x 10(6)/l. (C) 2000 Lippincott William s & Wilkins.