FOLLOW-UP OF PATIENTS WITH ACUTE/EARLY HIV INFECTION WITHIN A CONTROLLED CLINICAL TRIAL (CTN 124)

B Conway, P Côté, D Rouleau, R LeBlanc, M Ostrowski, J Singer, RP Sékaly, M Wainberg, JP Routy
University of British Columbia, Vancouver, British Columbia; University of Toronto, Toronto, Ontario; Clinique du Quartier Latin, Clinique Lori, McGill University and Université de Montréal, Montreal, Quebec

Objectives: Current guidelines suggest that HAART be considered in all patients presenting within one year of becoming infected with HIV. There are no controlled data to support this approach, nor has the optimal timing of initiation of therapy or any protocol for its discontinuation been established. CTN 124 was initiated to evaluate the safety and clinical, virologic and immunologic benefit of HAART (with or without a PI) in this setting.
Methods: This is a randomized, controlled, open label, multi-centre, phase III trial. Eligible patients are initially randomized to receive HAART (with or without a PI). After 16 weeks, all patients not achieving maximal virologic suppression will have their therapy intensified. All patients exhibiting maximal virologic suppression at 12 months would be considered for further intervention, including therapeutic interruption, with or without prior immune-based intervention.
Results: To date, we have enrolled 21 patients (17 men, 4 women, 8 IDUs). Of these, 18 had symptoms of acute HIV infection, and 7 presented with an incomplete anti-HIV antibody response. There was no evidence of primary drug resistance. All received 2 NRTIs (usually d4T/ddI) and 11 were placed on EFV and 10 on PIs. Median Baseline CD4 counts and plasma viral load measures were 388 cells/mm³ and 70 734 copies/mL. After a median 12 months, 16 patients remain on HAART, of which 12 have plasma viral load < 50 copies/mL. The median CD4 count is 538 cells/mm³.
Conclusions: HAART is very successful in achieving virologic suppression and maintaining immune function in the setting of acute/early infection. Patients enrolled in cohorts such as ours will be offered therapeutic simplification or interruption (with or without immune-based therapy) in the context of ongoing clinical trials designed to establish the optimal approach to individuals who have only recently become infected with HIV.

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