Objective: To investigate the efficacy and side effects of highly active antiretroviral therapy (HAART) in Chinese AIDS patients.
Methods: 45 antiretroviral drug-naive AIDS patients were enrolled and divided into two groups by their baseline CD(4) count < 100/microl or > or = 100/microl. Clinical, virological and immunological outcomes as well as side effects were followed at baseline and at the end of month 1, 3, 6, 9, 12 after receiving HAART.
Results: Among the 45 HIV/AIDS patients included, by the end of 12 months of HAART, the plasma viral load (VL) got a mean reduction by 2.8 lg copies/ml, CD(4) count had a mean gain of 187/microl, among which the naive phenotype increased by 68/microl and the memory phenotype by 119/microl. The CD(4)(+)CD(28)(+) T cell percentage went up from (62.5 +/- 25.8)% to (82.6 +/- 15.6)% (P < 0.001); and there was a significant reduction of CD(8)(+) T-cell activation. In the 31 patients with their baseline CD(4) count < 100/microl, 11 had a VL < 50 copies/ml, and 14 had fluctuations in their VL; while in 14 patients with their baseline CD(4) count > or = 100/microl, 10 had a VL < 50 copies/ml and 2 had fluctuations in their VL, respectively, with statistic significance between the two groups. CD(4) count showed a bi-phase increase during HAART and there was significant positive correlation between the change of CD(4) count and plasma VL. Throughout the 12 months of HAART, 39 patients had gastrointestinal side effects, 15 peripheral neuritis, 3 hepatic lesions, 4 hematological side effects and 1 renal calculus. 9 patients had adjustment of their initial therapy because of side effects.
Conclusions: Immune reconstitution as well as significant therapeutic effect was observed in advanced Chinese AIDS patients after HAART. Side effects were common during HAART, so close clinical attention is needed.