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O213 CD4-guided STI in patients responding to HAART

Purpose of the study

To compare continuous HAART with a CD4-driven STI strategy.

Methods

LOTTI is a randomized, controlled, prospective trial. Patients with HIV-RNA <50 copies/ml and CD4 counts >700 cells/mcL were randomised to continue HAART or to stop it; 350 cells/mcL was the immunologic threshold to resume HAART. The primary end-point is clinical: development of any opportunistic disease, death from any cause, or the occurrence of diseases, other than opportunistic, requiring hospital admission. Secondary end-points are major adverse effects, virologic failures and therapeutic costs. An interim ITT analysis at 4-years follow-up is presented.

Summary of results

329 patients were randomized. The total follow-up time is 1,388 person-years. Patients in the STI group performed a total of 241 STI cycles. On average, patients in the STI group were on HAART for 34.7% (mean 515 days) of follow-up time, in the control group this value raised to 98.3% (mean 1,530 days). The primary end point of the study occurred in 12.1% of patients on STI and in 11.6% of controls (OR 1.05; 95% CI 0.5–2.1). The 95% CI for the difference between groups was far below the pre-defined 12% limit assumed to define equivalence. Resistance-conferring mutations were selected in 4.8% of STI patients and in 6.7% of controls (OR 0.79; 95% CI 0.3–1.8). Grade 3 or 4 adverse events were observed in 27.4% of controls and only in 20.6% of patients in the STI group. The mean daily total cost for controls was 20.29 euros and it dropped to 9.07 euros in the STI arm (p < 0.0001).

Conclusion

CD4-guided STIs may be a possible alternative strategic option for chronically infected individuals responding to HAART provided that CD4 decrements would be steadily maintained above a safe threshold. STIs warrant further careful prospective evaluation especially to investigate virologic and clinical outcomes in the very long period.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Maggiolo, F., Airoldi, M., Callegaro, A. et al. O213 CD4-guided STI in patients responding to HAART. JIAS 11, O18 (2008). https://doi.org/10.1186/1758-2652-11-S1-O18

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-O18

Keywords

  • Prospective Trial
  • Infected Individual
  • Prospective Evaluation
  • Virologic Failure
  • Major Adverse Effect