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Background:  Between 1996 and 2000, many HIV-1-positive patients initiated HAART at a CD4⁺ T-lymphocyte count (CD4 count) > 350 cells/mm³, which is higher than advised in current guidelines. TRIESTAN is a prospective, non-randomized, multi-center study in which we evaluated the safety, efficacy, and benefit of discontinuing HAART in such patients.

Methods:  All HIV-1-positive patients who had initiated HAART at a CD4 count > 350 cells/mm³ and remained on therapy for at least 1 year, were identified from the ATHENA national observational cohort. Patients were actively offered the choice to either interrupt or continue HAART. Exclusion criteria were: CD4 count < 500 cells/mm³ or HIV RNA in plasma > 50 copies/mL in the 6 months prior to inclusion, antiretroviral experience before HAART, > 1 change of regimen because of virologic failure, and prior non-Hodgkin’s lymphoma or Kaposi’s sarcoma. Data on clinical and virologic parameters, toxicity, and quality of life were collected. Where appropriate, χ² and Wilcoxon tests were used to compare groups.

Results:  In total, 70 patients were enrolled of whom 45 (64%) interrupted and 25 (36%) continued HAART. The median CD4 count at start HAART was 476 (IQR 420 to 570) and 510 cells/mm³ (IQR 440 to 637) among patients who interrupted or continued HAART, respectively. At inclusion, i.e. the moment HAART could be stopped, the median CD4 count was 905 cells/mm³ (IQR 730 to 1150) and 850 cells/mm³ (IQR 659 to 1070), respectively. Duration of HAART use was similar in both groups:  69 months (IQR 12.9 to 87.8) in patients who interrupted and 57.2 months (IQR 42.4 to 73.4) in patients who continued. In the group that interrupted, no serious clinical or adverse events occurred after interruption. At the time of analysis, 18 patients had reached week 36. At that time, the median plasma HIV RNA in this group was 4.3 log₁₀ copies/mL (IQR 4.2 to 4.6). The median CD4 count at 36 weeks still exceeded the pre-HAART count:  648 cells/mm³ (IQR 530 to 881). Three patients reinitiated HAART for personal reasons. None of the patients restarted HAART because of a decline in CD4 count or a new AIDS diagnosis CD4 counts and HIV RNA levels in the group who continued HAART remained stable until 36 weeks.

Conclusions:  Preliminary results indicate that patients who started HAART > 350 CD4⁺ T-cells/mm³ can interrupt HAART safely for at least 36 weeks. Most importantly, CD4 counts remained above CD4 levels at the start of HAART.

Keywords: treatment interruption; prospective; early starters