Background: A favorable development of CD4+ T cells was noticed in therapy-naive HIV-patients without antiretroviral therapy (ART) taking 5 mg prednisolone daily. Based on these encouraging observations, prednisolone therapy in further HIV-patients without antiretroviral therapy was initiated.

Objective: To evaluate the effect of low dose prednisolone on therapy-naive HIV patients without antiretroviral therapy.

Methods: A retrospective analysis has been conducted comparing the development of CD4+ T cells, viral load and clinical outcome in all therapy-naive HIV-patients with (n = 65; CD4 > or =300/microl) or without (n = 136; CD4 > or =300/microl) prednisolone treatment for > or =6 months.

Results: After 3 years, therapy-naive patients on prednisolone therapy showed a CD4+ T cell increase of +50.1/microl whereas in the untreated group a decrease of -186.1/microl (p = 0.0021) was noted. After 12 months, nearly twice as much untreated patients experienced a first-time CD4+ T cell loss of >100/microl or initiation of HAART due to clinical development compared to prednisolone-treated patients (64.1% vs. 35.0%). CD4+ T cell increase was associated with viral load at baseline: Patients with lower viral loads at baseline (<30,000 copies/ml) showed a favorable development with statistically significant less drop-outs (defined as HAART-onset and/or prednisolone discontinuation for the prednisolone group) than patients with higher viral loads at baseline in the first 3 years in the prednisolone group. -

Conclusion: Low dose prednisolone seems to be associated with a stabilization of CD4+ T cell count in therapy-naive HIV patients resulting in a pronounced prolongation of the potential time without HAART for many HIV patients.

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